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Zalecenia dla podmiotów odpowiedzialnych

Wysłane przez marpie w Czw, 31/03/2016 - 14:09

ZALECENIA DLA PODMIOTÓW ODPOWIEDZIALNYCH

Substancja czynna

Zalecenia

Podstawa prawna

Termin złożenia zmiany

Data notyfikacji decyzji Komisji Europejskiej

Klasyfikacja zmiany

17-alpha-oestradiol (topical) [1]

PSUR worksharing

-

-  

IB nr C.I.3 z)

5 fluorouracil [2]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

5-fluorouracil  [3]
(i.v. application) [3]
Stanowisko CMDh -
02/01/2019
 
  IAIN nr C.I.3 a)

99mTc-human albumin macro-aggregates [4]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Abirateron [5]

Pojedyncze sygnały   10/04/2020   IAIN nr C.I.z

Acenocoumarol [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Acetazolamid [7]

Pojedyncze sygnały

- 23/12/2017   IAIN nr C.I.z

Acetylsalicylic acid [8]

Pediatryczny worksharing

Art. 45

Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Acitretin [9]

Stanowisko CMDh

-

05/10/2016

 

IAIN nr C.I.3 a)

Adalimumab [10] Pojedyncze sygnały   08/04/2021   IAIN nr C.I.z

Adapalene / benzoyl peroxide [11]

Stanowisko CMDh - 12/09/2018   IAIN nr C.I.3 a)

Agomelatine [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

AirFluSal Forspiro and associated names (salmeterol xinafoate and fluticasone propionate) [13]

Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Aksytynib [14]

Pojedyncze sygnały

-

11/06/2016

 

IAIN nr C.I.z

Albiglutide [15]

Pojedyncze sygnały

-

02/07/2017

 

IAIN nr C.I.z

Aldesleukin [16] Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Alemtuzumab [17]

Pojedyncze sygnały   01.12.2018   IAIN nr C.I.z
Alemtuzumab [18] Pojedyncze sygnały   31/07/2021   IAIN nr C.I.z

Allopurinol [19]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)

Alprostadil (erectile dysfunction) [20]

Stanowisko CMDh

-

25/01/2017

 

IAIN nr C.I.3 a)

Alprostadil (indicated in peripheral arterial occlusive diseases) [21] Stanowisko CMDh - 08/08/2018   IAIN nr C.I.3 a)

Alteplase [22]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Altizide, Spironolactone [23]

Stanowisko CMDh

-

06/01/2016

 

 IAIN nr C.I.3 a)

Amiodarone [24]

Stanowisko CMDh

-

04/11/2015

 

IAIN nr C.I.3 a)

Amantadine [25] Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Amitriptyline [26]

Stanowisko CMDh

-

03/02/2016

 

IAIN nr C.I.3 a)

Amitriptyline [27]

Pojedyncze sygnały

  07.07.2018   IAIN nr C.I.z

Amitriptyline/perphenazine [28]

Stanowisko CMDh

-

03/02/2016

 

IAIN nr C.I.3 a)

Amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide [29] Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Amlodypine [30]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Amlodipine + Atorvastatine [31]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Amlodipine besilate / Ramipril [32]

Stanowisko CMDh

-

30/03/2016

 

IAIN nr C.I.3 a)

Amoxicillin [33]

Pojedyncze sygnały

- 07/10/2017  

IAIN nr C.I.z

Amoxicillin + clavulanic acid [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Amphotericin B [34]

Pediatryczny worksharing

Art. 45

Rozp. 1901/2006

03/07/2018*

02/08/2018**

  IB nr C.I.3 z)

Ampicillin-sulbactam [35]

Stanowisko CMDh

-

03/02/2016

 

IAIN nr C.I.3 a)

Anakinra [36]

Pojedyncze sygnały

-

03/01/2016

 

IAIN nr C.I.z

Anakinra, kanakinumab [37] Pojedyncze sygnały   06/07/2021   IAIN nr C.I.z
Anastrozol [10] Pojedyncze sygnały   08/04/2021   IAIN nr C.I.z

Andeksanet alfa [38]

Pojedyncze sygnały   11/07/2020   IAIN nr C.I.z

Antithrombin III [39]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Apiksaban, edoksaban [40]

Pojedyncze sygnały - 11.08.2018   IAIN nr C.I.z

Apomorphine [41]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Apomorphine [42]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Argatroban [43]

Stanowisko CMDh

-

03/02/2016

 

IAIN nr C.I.3 a)

Asmanex Twisthaler (mometasone furoate) 
UK/W/0064/pdWS/005
[44]

Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Asparaginase [45]

Stanowisko CMDh

-

10/08/2016

 

IAIN nr C.I.3 a)

Atenolol / Chlortalidone [46]

Stanowisko CMDh

-

20/08/2015

 

IAIN nr C.I.3 a)

Atorvastatin [47]

 PSUR worksharing -  -    IB nr C.I.3 z)

Atorvastatin [48]

Stanowisko CMDh   10/10/2018   IAIN nr C.I.3 a)

Atovaquone and proguanil hydrochloride [49]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Atracurium [50]

PSUR worksharing -  25/01/2018   IB nr C.I.3 z)

Azacitidine [51]

Stanowisko CMDh

-

06/04/2017

 

IAIN nr C.I.z

Azathioprine [14]

Pojedyncze sygnały

-

11/06/2016

 

IAIN nr C.I.z

Azatiopryna [52] Pojedyncze sygnały   03/07/2021   IAIN nr C.I.z

Azithromycin (systemic use formulation) [53]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Azytromycyna; klarytromycyna; erytromycyna; roksytromycyna [7]

Pojedyncze sygnały

- 23/12/2017   IAIN nr C.I.z

Bazedoksyfen + Estrogen [54]

Pojedyncze sygnały

-

06/04/2016

 

IAIN nr C.I.z

Bacillus clausii multi-antibioresistant spores [55]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)

Baclofen (oral) [56]

Stanowisko CMDh

-

04/10/2017

 

IAIN nr C.I.3 a)

Barycytynib [57] Pojedyncze sygnały   23/08/2020   IAIN nr C.I.z

BCG vaccine (freeze-dried) [58]

Stanowisko CMDh - 27/02/2019   IAIN nr C.I.3 a)

Beclomethasone (excluding cutaneous formulations) [59]

Pojedyncze sygnały

-

21/02/2017

 

IAIN nr C.I.z

Bemetizide / Triamterene [60]

Stanowisko CMDh

-

08/06/2016

 

IAIN nr C.I.3 a)

Benazepril [61]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Bendamustine/hydrochloride [62]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Bendamustine hydrochloride  [63]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)
Bendroflumethiazide, bendroflumethiazide / potassium chloride [64] Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Benzydamine [65]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Berinert (C1-esterase inhibitor, human)  [66]
DE/W/0051/pdWS/003 [66]
Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Bilastine [67]

Stanowisko CMDh

-

24/01/2017

 

IAIN nr C.I.3 a)

Bilastine [68]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Bismuth subcitrate potassium / Metronidazole / Tetracycline [69]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Bismuth subcitrate potassium /metronidazole /tetracycline [70]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Boceprevir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Botulinum neurotoxin type a (150 d) free from complexing proteins [71]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Botulinum toxin a - haemagglutinin complex  [72]

Stanowisko CMDh

-

18/12/2016

 

IAIN nr C.I.3 a)

Botulinum toxin a [73]

Stanowisko CMDh

-

18/12/2016

 

IAIN nr C.I.3 a)

Brentuximab vedotin [74]

Pojedyncze sygnały

-

29/07/2017

 

IAIN nr C.I.z

Bromazepam [75]

PSUR worksharing - 23/01/2018   IB nr C.I.3 z)

Brotizolam [76]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Budesonide  [77]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Budesonide [78]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Budesonide + Formoterol [79]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Buflomedil hydrochloride [80]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Bumetadine [81]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
03/12/2018* 
31/12/2018**
  IB nr C.I.3 z)
Buprenorfina; buprenorfina, nalokson [57] Pojedyncze sygnały   23/08/2020   IAIN nr C.I.z

Buprenorphine [82]

PSUR worksharing

-

11/04/2017

 

IB nr C.I.3 z)

Bupropion [83]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Cabergoline [84]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Calcium carbonate / famotidine / magnesium hydroxide [85]

Stanowisko CMDh - 12/09/2018   IAIN nr C.I.3 a)

Calcium carbonate, Famotidine, Magnesium hydroxide [86]

                       Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Calcium carbonate + Cholecalciferol [87]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Calcium chloride dihydrate, Sodium chloride, Sodium (S)-lactate solution, Magnesium chloride hexahydrate, Glucose monohydrate [88]

PSUR worksharing - Bez konieczności złożenia zmian   Bez konieczności złożenia zmian

Calcium valproate [89]

Stanowisko CMDh

-

                           06/01/2016

 

IAIN nr C.I.3 a)

Candesartan/Candesartan+ Hydrochlorothiazide [90]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Candesartan, 
Candesartan /hydrochlorothiazide
[91]

Stanowisko CMDh - 08/05/2018   IAIN nr C.I.3 a)

Captopril / Hydrochlorothiazide [92]

Stanowisko CMDh

-

23/03/2017

 

IAIN nr C.I.3 a)

Captopril + Hydrochlorothiazide [93]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Carboplatin [94]

Stanowisko CMDh

-

25/01/2017

 

IAIN nr C.I.3 a)

Carbidopa/levodopa [95]

Stanowisko CMDh

-

04/10/2017

 

IAIN nr C.I.3 a)

Carmustine (powder and solvent for solution for infusion) [96]

Stanowisko CMDh

-

30/03/2016

 

IAIN nr C.I.3 a)

Carteolol [97]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Cefadroxil [98]

Stanowisko CMDh - 04/07/2018   IAIN nr C.I.3 a)

Cefalexin [99]

Pojedyncze sygnały  - 03.06.2018   IAIN nr C.I.z

Cefepime [100]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ceftriakson [101] Pojedyncze sygnały   23.01.2021   IAIN nr C.I.z

Cefoperazone/sulbactam [102]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Cefoperazone [103]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Cefotaxime [104]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Cefuroxime sodium (except for intracameral use) [105]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)

Ceftazidime [106]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Certican (everolimus) 
SE/W/0025/pdWS/003
[107]

Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Cetirizine [108]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Certizne / pseudoephedrine [109]

Stanowisko CMDh

-

30/08/2017

 

IAIN nr C.I.3 a)

Cisplatin [110]

Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Chlormadinone [111]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)
Chlorochina, hydroksychlorochina [112] Pojedyncze sygnały   06.03.2021   IAIN nr C.I.z

Chloroquine [113]

Stanowisko CMDh

-

14/07/2016

 

IAIN nr C.I.3 a)

Chloroquinaldol (vaginal tablet) / promestriene [114]

Stanowisko CMDh

-

30/08/2017

 

IAIN nr C.I.3 a)

Chlorpromazine [115]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Chlorprothixene hydrochloride [116]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Cholekalcyferol [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Ciclopirox olamine (shampoo only) [118]

PSUR worksharing - Nie dotyczy   Bez konieczności złożenia zmian

Ciclosporin [119]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Cilazapril, cilazapril / hydrochlorothiazide [120]

Stanowisko CMDh - 30/01/2019   IAIN nr C.I.3 a)

Cilostazol [121]

Stanowisko CMDh

-

03/02/2016

 

 IAIN nr C.I.3 a)

Ciprofloxacin [122]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ciprofloxacin [123]

Stanowisko CMDh - 30/01/2019   IAIN nr C.I.3 a)
Ciprofloxacin Decyzja Komisji Europejskiej art. 31   12/03/2019 IAIN nr C.I.1 a)/
IB nr C.I.1 b

Ciprofloxacin (solutions for infusion) [33]

Pojedyncze sygnały

-

07/11/2017

 

IAIN nr C.I.z

Citalopram; deswenlafaksyna; escytalopram; fluoksetyna fluwoksamina; milnacypran; paroksetyna; sertralina; wenlafaksyna; wortioksetyna [124]

Pojedyncze sygnały   26.12.2020   IAIN nr C.I.z

Ciprofloxacin hydrochloride + Dexamethasone acetate (ear drops, suspension) [125]

                                 PSUR worksharing

-

-

 

IB nr C.I.3 z)

Clarithromycin [126]

PSUR worksharing

-

11/09/2016

 

IB nr C.I.3 z)

Clarithromycin [127]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)

Clebopride [128]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Clevidipine [129]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Clodronate [130]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Clostridium botulinium neurotoxin type A haemagglutinin complex [131]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Clostridium botulinum toxin [132] Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
06/08/2018* 
05/09/2018**
  IB nr C.I.3 z)

Cobicistat [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Codeine [133]

Stanowisko CMDh

Art. 31

20/07/2015

 

IB nr C.I.1 a) lub IB nr C.I.1 b)

Comirnaty [134] Pojedyncze sygnały   01.11.2021   IAIN nr C.I.z

Corticorelin [135]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Corticosteroids other than beclomethasone (excluding cutaneous formulations) [59]

Pojedyncze sygnały

-

21/02/2017

 

IAIN nr C.I.z

Cyproheptadine [136]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Cyproterone acetate/Ethinylestradiol [137]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Daclatasvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Daklataswir [138]

Pojedyncze sygnały

-

13/06/2015

 

IAIN nr C.I.z

Danaparoid [139]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Dapoxetine [140]

Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Darbepoetin alfa [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Dasabuvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Daunorubicin [141]

Stanowisko CMDh

-

08/06/2016

 

IAIN nr C.I.3 a)

Dazatynib [142]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Dazatynib [27]

Pojedyncze sygnały

- 07.07.2018   IAIN nr C.I.z
Dabrafenib, trametynib [101] Pojedyncze sygnały   23.01.2021   IAIN nr C.I.z

Dekslanzoprazol [143]

Pojedyncze sygnały

-

07/11/2015

 

IAIN nr C.I.z

Delapril [144]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Delapril / manidipine, delapril /inapamide [145]

Stanowisko CMDh - 21/06/2018   IAIN nr C.I.3 a)

Deoxycholic acid [146]

PSUR worksharing - 18/02/2018   IB nr C.I.3 z)

Deoxycholic acid [147]

Stanowisko CMDh   10/10/2018   IAIN nr C.I.3 a)

Deoxycholic acid [148]

Stanowisko CMDh - 27/03/2019   IAIN nr C.I.3 a)

Deoxyribonuclease human (dornase alpha) [149]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Desloratadyna, loratadyna [7]

Pojedyncze sygnały - 23/12/2017   IAIN nr C.I.z

Desogestrel [150]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Dexamethasone (apart from centrally authorised products) [151]

Stanowisko CMDh

-

02/02/2017

 

IAIN nr C.I.3 a)

Dexamfetamine [152]

Stanowisko CMDh - 08/08/2018   IAIN nr C.I.3 a)

Dexlansoprazole [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Dexlansoprazole [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Dexlansoprazole, lansoprazole [154]

Stanowisko CMDh - 28/12/2017   IAIN nr C.I.3 a)

Dexibuprofen [155]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Dexketoprofen [156]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Dextromethorphan [157]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Dezogestrel [158] Pojedyncze sygnały   06/09/2020   IAIN nr C.I.z

Diacerein [159]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)

Diclofenac /misoprostol [160]

Stanowisko CMDh - 04/07/2018   IAIN nr C.I.3 a)

Diclofenac (systemic formulations) [161]

Stanowisko CMDh

-

07/09/2016

 

IAIN nr C.I.3 a)

Didanosine [162]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Dinoprostone [163]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Diovan and related names (valsartan) [164]

Pediatryczny worksharing

Art. 46
Rozp. 1901/2006

24/11/2017*
24/12/2017**

  IB nr C.I.3 z)

Diovan and related names (valsartan)
SE/W/0026/pdWS/002
[165]

Pediatryczny worksharing

Art. 46
Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Doksycyklina [7]

Pojedyncze sygnały    23/12/2017   IAIN nr C.I.z

Dolutegrawir [166]

Pojedyncze sygnały   

29.12.2018

 

IAIN nr C.I.z

Domperidone [167]

Stanowisko CMDh

-

01/11/2017

 

IAIN nr C.I.3 a)

Donepezil [143]

Pojedyncze sygnały

-

07/10/2015

 

IAIN nr C.I.z

Dorzolamide [168]

Stanowisko CMDh

-

22/02/2017

 

IAIN nr C.I.3 a)

Dorzolamide + Timolol [169]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Doxazosin [170]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Doxylamine [171]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Doxycycline [172]

Pediatryczny worksharing Art. 45 
Rozp. 1901/2006
01/05/2018* 
31/05/2018**
  IB nr C.I.3 z)

Drospirenone and Ethinylestradiol [173]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Dulaglutyd [174]

Pojedyncze sygnały  - 05/04/2018   IAIN nr C.I.z

Duloksetyna [17]

Pojedyncze sygnały

  01.12.2018   IAIN nr C.I.z
Durvalumab [175] Pojedyncze sygnały   07.04.2022   IAIN nr C.I.z

Dutasteride [176]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ebastine [177]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Econazole [178]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Elbasvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Enalapril [179]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Enoxacin Decyzja Komisji Europejskiej art. 31   12/03/2019  IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Epinastine [180]

Stanowisko CMDh   10/10/2018   IAIN nr C.I.3 a)

Epinastine hydrochloride [181]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Epirubicin [182]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Epoetin alfa [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Epoetin beta [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Epoetin theta [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Epoetin zeta [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Epoprostenol [183]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)

Eprosartan hydrochlorothiazide [184]

PSUR worksharing - 05/03/2018   IB nr C.I.3 z)

Eprosartan mesylate [185]

PSUR worksharing - 05/03/2018   IB nr C.I.3 z)
Ertapenem [186] Pojedyncze sygnały   22.01.2022   IAIN nr C.I.z

Erythromycin and erythromycin in combination (topical) [187]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Esomeprazole [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Esomeprazole [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Estradiol valerate + Dienogest [188]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Estradiol + Norethisterone [189]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Estrogen [54]

Pojedyncze sygnały

-

06/04/2016

 

IAIN nr C.I.z

Estrogen + Progestagen [54]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Estrogen + Progestagen [54]

Pojedyncze sygnały

-

06/04/2016

 

IAIN nr C.I.z

Ethinylestradiol + Dienogest [190]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ethinylestradiol + Levonorgestrel [191]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ethinylestradiol / gestodene (tranasdermal applicatation) [192]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Etomidate [193]

PSUR worksharing

-

23/10/2017

 

IB nr C.I.3 z)

Etomidate [194]

Stanowisko CMDh - 12/09/2018   IAIN nr C.I.3 a)

Etoposide phosphate

Decyzja Komisji Europejskiej art. 30 - 27.06.2017 r. IB nr C.I.1 b)

Etrogen [54]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Everolimus (indicated for rejection of transplanted organs) [195]

Stanowisko CMDh

-

14/07/2016

 

IAIN nr C.I.3 a)

Ezetimibe [196]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ezetimibe /rosuvastatin [197]

Stanowisko CMDh - 04/07/2018   IAIN nr C.I.3 a)

Ezetimibe /simvastatin [198]

PSUR worksharing - 01/05/2018   IB nr C.I.3 z)

Ezomeprazol [143]

Pojedyncze sygnały

-

07/11/2015

 

IAIN nr C.I.z

Famotidine [199]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Famotidine [200]

Stanowisko CMDh - 12/09/2018   IAIN nr C.I.3 a)

Felbamate [201]

Stanowisko CMDh

-

04/10/2017

 

IAIN nr C.I.3 a)

Felodipine + Ramipril [202]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fenoterol hydrobromide + Ipratropium bromide [203]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fenprokumon [27]

Pojedyncze sygnały - 07.07.2018   IAIN nr C.I.z

Fenspiride [204]

Stanowisko CMDh - 27/02/2019   IAIN nr C.I.3 a)

Fentanyl [205]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ferrous sulfate [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Ferumoxsil [206]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Filgrastym; lenograstym; lipegfilgrastym; pegfilgrastym [207]

Pojedyncze sygnały - 05.05.2018    

Finasteride [208]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Finasteride [209]

Stanowisko CMDh

-

03/08/2017

 

IAIN nr C.I.3 a)

Finasteride [210] Stanowisko CMDh - 08/08/2018   IAIN nr C.I.3 a)

Fingolimod [211]

Pojedyncze sygnały

-

01/08/2015

 

IAIN nr C.I.z

Fixed combination containing: Dimethyl sulfoxide,Camphor, Tterebinthini aetheroleum,Benzyl nicotinate, Nonivamide [212]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Flubendazole [213]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Flucloxacillin [59]

Pojedyncze sygnały

-

21/02/2017

 

IAIN nr C.I.z

Fluconazole [214]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fluconazole [215]

Pojedyncze sygnały

-

06/05/2017

 

IAIN nr C.I.z

Fluids containing carbohydrates (intravenous) [33]

Pojedyncze sygnały

-

07/02/2018

 

IAIN nr C.I.z

Fluids containing electrolytes (intravenous) [33]

Pojedyncze sygnały

-

07/02/2018

 

IAIN nr C.I.z

Fluindione [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Flukloksacylina [7]

Pojedyncze sygnały - 23/12/2017   IAIN nr C.I.z

Flumazenil [216]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fluorochinolony do stosowania ogólnego i wziewnego  [17]

Pojedyncze sygnały

  01.12.2018   IAIN nr C.I.z

Fluorodopa (18F) [217]

Stanowisko CMDh - 27/02/2019   IAIN nr C.I.3 a)

Fluoxetine [218]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fluticasone [219]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fluticasone propionate [220]

Stanowisko CMDh - 21/02/2018   IAIN nr C.I.3 a)

Fluvoxamine [221]

PSUR worksharing - 04/07/2018   IB nr C.I.3 z)

Fluvastatin [222]

Stanowisko CMDh - 12/09/2018   IAIN nr C.I.3 a)

Folic acid [223]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Folinic acid / (di)sodium folinate / Calcium folinate / Calcium levofolinate [224]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Formoterol [225]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Fulvestrant [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Fumaran dimetylu (Tecfidera) [17]

Pojedyncze sygnały

  01.12.2018   IAIN nr C.I.z

Furosemide/Spironolactone [226]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Furosemide [227]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Fusidic acid and Sodium fusidate [228]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Gabapentin [229]

Stanowisko CMDh

-

25/01/2017

 

IAIN nr C.I.3 a)

Gabapentin [230]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Gabapentin [231]

Pojedyncze sygnały

-

03/09/2017

 

IAIN nr C.I.z

Gadobenic acid [232]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gadobenic acid

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadobutrol [233]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gadobutrol

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 r. IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadodiamid [234]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Gadodiamide [235]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gadodiamide

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadopentetic acid dimeglumine [236]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Gadopentetic acid [237]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gadopentetic acid

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadoteric acid (IV and intravascular formulations) [238]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gadoteric acid

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 r. IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadoteridol [239]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gadoteridol [240]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Gadoteridol

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadoxetic acid

Decyzja Komisji Europejskiej art. 31 - 24/11/2017 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Gadoxetic acid disodium [241]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Gemcitabine [242]

Stanowisko CMDh - 02/01/2019   IAIN nr C.I.3 a)

Gentamicin (systemic use) [243]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)
Genotropin and associated names (somatropin) 
DK/W/008/pdWS/007
[244]
Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
24/11/2018*
24/12/2018**
   IB nr C.I.3 z)

Gilnacipran [245]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Glatiramer [246]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Glibenclamide / Metformin hydrochloride [247]

Stanowisko CMDh

-

08/06/2016

 

IAIN nr C.I.3 a)

Glucosamine [248]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)

Glycopyrronium bromide [249]

(all indications except for chronic obstructive pulmonary disease) [250]

Stanowisko CMDh

-

07/09/2016

 

IAIN nr C.I.3 a)

Glycopyrronium / Neostigmine [251]

Stanowisko CMDh

-

07/09/2016

 

IAIN nr C.I.3 a)

Golimumab [5]

Pojedyncze sygnały   10/04/2020   IAIN nr C.I.z

Granisetron (other formulations except for transdermal patch) [252]

Stanowisko CMDh

-

22//02/2017

 

IAIN nr C.I.3 a)

Grazoprevir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Haemophilus type b
conjugate vaccines
[253]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Haloperidol decanoate

Decyzja Komisji Europejskiej art. 30 - 02.05.2017 IB nr C.I.1 b)

Haloperidol

Decyzja Komisji Europejskiej art. 30 - 02/05/2017 IB nr C.I.1 b)

Haloperidol

korekta Decyzji Komisji Europejskiej art. 30 - 13/06/2017 IB nr C.I.1 b)
Havrix Junior 720 (inactivated Hepatitis A virus antigen) [254] Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
-
Nie dotyczy
Bez konieczności złożenia zmian
Hormonalna terapia zastępcza (HTZ): chlorotrianizen; skoniugowane estrogeny; skoniugowane estrogeny, bazedoksyfen; dienestrol; dietylostylbestrol; estradiol; estradiol, noretysteron; estriol; estron; etynyloestradiol; metalenestryl; moksestrol; promestrien; tibolon [57] Pojedyncze sygnały   23/09/2020   IAIN nr C.I.z
Hormonalna terapia zastępcza (HTZ): tibolon [158] Pojedyncze sygnały   06/09/2020   IAIN nr C.I.z

Hormonalne środki antykoncepcyjne [166]

(Chlormadynon, estradiol; octan chlormadynonu, etynyloestradiol ; estrogeny skoniugowane, medrogeston; estrogeny skoniugowane, octan medroksyprogesteronu; estrogeny skoniugowane, norgestrel; cyproteron, etynyloestradiol; octan cyproteronu,walerianian estradiolu; dezogestrel; dezogestrel ,etynyloestradiol; dienogest, estradiol; dienogest, etynyloestradiol; drospirenon, estradiol; drospirenon, etynyloestradiol; estradiol, estriol, lewonorgestrel; estradiol, gestoden; estradiol, lewonorgestrel; estradiol, octan medroksyprogesteronu; estradiol, octan nomegestrolu; estradiol, noretysteron; estradiol, norgestymat; estradiol (17-beta), progesteron; estradiol (17-beta), trimegeston; walerianian estradiolu, norgestrel; etynyloestradiol, etonogestrel; etynyloestradiol, etynodiol; etynyloestradiol, gestoden; etynyloestradiol, gestoden; etynyloestradiol, lewonorgestrel; etynyloestradiol, linestrenol; etynyloestradiol, noretysteron; [166]

etynyloestradiol, norgestymat; etynyloestradiol, norgestrel; lewonorgestrel, etynyloestradiol; etynyloestradiol; lewonorgestrel; medroksyprogesteron; mestranol, noretysteron; nomegestrol; octan nome gestrolu estradiol; norelgestromin, etynyloestradiol; noretysteron [166]

Pojedyncze sygnały

 

29.12.2018

 

IAIN nr C.I.z

Human coagulation factor VII [255]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Human coagulation factor VIII

Decyzja Komisji Europejskiej art. 31 - 13.11.2017 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Human coagulation factor VIII inhibitor bypassing fraction [256]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Human coagulation factor VIII inhibitor bypassing fraction [257]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Human fibirinogen [258]

PSUR worksharing - 31/12/2018   IB nr C.I.3 z)

Humatrope (somatropin) NL/W/0007/pdWS/002 [259]

Pediatryczny worksharing

Art. 46

Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Humatrope(somatropin) 
NL/W/0007/pdWS/003
[260]

Pediatryczny worksharing

Art. 46

Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Humatrope(somatropin)
NL/W/0007/pdWS/004
[261]

Pediatryczny worksharing

Art. 46

Rozp. 1901/2006

03/06/2018*

03/07/2018**

  IB nr C.I.3 z)

Humatrope (somatropin)
NL/W/0007/pdWS/005
[262]

Pediatryczny worksharing

Art. 46

Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Priorix (measles, mumps and rubella vaccine)
DE/W/0055/pdWS/004
[263]

Pediatryczny worksharing

Art. 46

Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Hydrochlorothiazide, Spironolactone [264]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Hydrochlorotiazyd [17]

Pojedyncze sygnały

  01.12.2018   IAIN nr C.I.z
Hydrokortyzon [10] Pojedyncze sygnały   08/04/2021   IAIN nr C.I.z

Hydroksykarbamid [207]

Pojedyncze sygnały  - 05.05.2018   IAIN nr C.I.z

Hydromorphone [265]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Hydroquinidine [266]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Hydroxyzine [267]

Stanowisko CMDh

Art. 31

19/06/2015

 

IB nr C.I.1 a) lub IB nr C.I.1 b)

Hydroxycarbamide (except for centrally authorised product) [268]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)
Ibrutynib [101] Pojedyncze sygnały   23.01.2021   IAIN nr C.I.z

Ibuprofen- and dexibuprofen [269]

Stanowisko CMDh

Art. 31

16/10/2015

 

IB nr C.I.1 a) lub IB nr C.I.1 b)

Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus) [270]

Stanowisko CMDh - 21/02/2018    IAIN nr C.I.3 a)

Ibuprofen, ketoprofen i produkty złożone o stałej dawce do stosowania ogólnego [38]

Pojedyncze sygnały   11/11/2020   IB C.I.z

Ibuprofen / pseudoephedrine [271]

Stanowisko CMDh - 06/06/2018   IAIN nr C.I.3 a)

Ibutilide [272]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Idarubicin [273]

PSUR worksharing

-

-

 

 IB nr C.I.3 z)

Idelalizyb [38]

Pojedyncze sygnały   11/07/2020   IAIN nr C.I.z

Imatynib [142]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Imipenem/cilastatin [274]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Immunoglobulina ludzka normalna do podawania dożylnego [275]

Pojedyncze sygnały

  06.11.2018   IAIN nr C.I.z

Inactivated hepatitis A virus antigen [276]

Pediatryczny worksharing

Art. 45
Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian

Inactivated influenza split trivalent vaccine [277]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Indium (In-111) chloride solution [278]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

 Indobufen [279]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Infanrix [280]

Pediatryczny worksharing Art. 45
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Influenza vaccine (surface antigen, inactivated) [281]

Stanowisko CMDh

-

-

 

IAIN nr C.I.3 a)

Inhibitory immunologicznych punktów kontrolnych: atezolizumab, cemiplimab, durwalumab [282] Pojedyncze sygnały   Pojedyncze sygnały   IAIN nr C.I.z
Inhibitory czynnika martwicy nowotworu alfa: adalimumab; certolizumab pegol; etanercept; golimumab; infliksymab [283] Pojedyncze sygnały   03/10/2020   IAIN nr C.I.z

Insulin (pre-filled pens and cartridges) [284]

Pojedyncze sygnały

-

28/07/2017

 

IAIN nr C.I.z

Insulina (wstrzykiwacze napełnione i wkłady); insulina aspart, insulina bydlęca; insulina degludec; insulina; liraglutyd; insulina detemir; insulina glargine, insulina glulizynowa; insulina ludzka (rDNA), insulina izofanowa; insulina listro; insulina wieprzowa  [285]

Pojedyncze sygnały  - 04/03/2018   IAIN nr C.I.z

Insulina (dot. wszystkich produktów zawierających insulinę) [38]

Pojedyncze sygnały   11/07/2020   IAIN nr C.I.z

Interferon alfa-2a [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Interferon alfa-2a [286]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Interferon alpha-2a [287]

Stanowisko CMDh - 06/06/2018   IAIN nr C.I.3 a)

Interferon alfa-2b [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Interferon beta-1a [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Interferon beta-1b [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Iobitridol [288]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Iodine (131i) Iobenguane [289]

Stanowisko CMDh

-

07/09/2016

 

IAIN nr C.I.3 a)

Iomeprol [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Ipilimumab [17]

Pojedyncze sygnały

  01.12.2018   IAIN nr C.I.z

Ipratropium [290]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ipratropium + Salbutamol [291]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ipratropium / salbutamol [292]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Irinotecan [293]

PSUR worksharing - 18/02/2018   IB nr C.I.3 z)

Irinotecan (except for liposomal formulation) [294]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Iron parenteral preparations [295]

Stanowisko CMDh   03/12/2018   IAIN nr C.I.3 a)

Isoniazid [296]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Isotretinoin (oral formulations) [297]

Stanowisko CMDh - 01/11/2017   IAIN nr C.I.3 a)

Isotretinoin (oral formulations) [298]

Stanowisko CMDh - 27/03/2019   IAIN nr C.I.3 a)

Isradipine [299]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ivermectin [300]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ivermectin (topical use) [301]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)

Ivermectin (topical use) [302]

Stanowisko CMDh

-

29/03/2017

 

IAIN nr C.I.3 a)

Kapecytabina [112] Pojedyncze sygnały   06.03.2021   IAIN nr C.I.z

Karbidopa [142]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Ketamine [303]

Pediatryczny worksharing

Art. 45
Rozp. 1901/2006

24/12/2017*
23/01/2018**

  IB nr C.I.3 z)

Ketoprofen (except topical use) [304]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ketoprofen for topical use [305]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Kladrybina [7]

Pojedyncze sygnały - 23/12/2017   IAIN nr C.I.z
Klindamycyna do stosowania ogólnego  [18] Pojedyncze sygnały   31/07/2021   IAIN nr C.I.z
Koniugat trastuzumabu z emtanzyną [37] Pojedyncze sygnały   06/06/2021   IAIN nr C.I.z

Kwas alendronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas etydronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas ibandronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas klodronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas nerydronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas pamidronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas ryzedronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas tioktynowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas tyludronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Kwas zoledronowy [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Ksylometazolina [306]

Pojedyncze sygnały -

26.02.2019

 

IAIN nr C.I.z

Labetalol [307]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Labetalol [186] Pojedyncze sygnały   22.01.2022   IAIN nr C.I.z

Lamotrigine [308]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Lamotrigine [309]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)
Lamotrygina [101] Pojedyncze sygnały   23.01.2021   IAIN nr C.I.z

Landiolol hydrochloride [310]

PSUR worksharing - 20/03/2018   IB nr C.I.3 z)

Lansoprazole [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Lansoprazole [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Lanthanum [311]

Stanowisko CMDh - 28/03/2018   IAIN nr C.I.3 a)

Lanzoprazol [143]

Pojedyncze sygnały

-

07/11/2015

 

IAIN nr C.I.z

Lapatynib [27]

Pojedyncze sygnały

- 07.07.2018   IAIN nr C.I.z

Latanoprost [211]

Pojedyncze sygnały

-

01/08/2015

 

IAIN nr C.I.z

Latanoprost/Timolol [312]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ledipasvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Ledipaswir [138]

Pojedyncze sygnały

-

13/06/2015

 

IAIN nr C.I.z

Leflunomide [15]

Pojedyncze sygnały

-

02/07/2017

 

IAIN nr C.I.z

Leflunomid [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Leflunomid [211]

Pojedyncze sygnały

-

01/08/2015

 

IAIN nr C.I.z

Leki przeciwretrowirusowe [275]

Pojedyncze sygnały

- 06.11.2018   IAIN nr C.I.z
Leki przeciwwirusowe o działaniu bezpośrednim (DAAV) wskazanym w leczeniu wirusowego zapalenia wątroby typu C [166]
(Daklatazwir; dazabuwir; elbazwir, grazoprewir; glekaprewir, pibrentazwir; ledipazwir, sofosbuwir; ombitazwir, paryteprewir, rytonawir; sofosbuwir; sofosbuwir, welpatazwir; sofosbuwir, welpatazwir, woksylaprewir) [166]
Pojedyncze sygnały - 29.12.2018  

IAIN nr C.I.z

Lenalidomid [40]

Pojedyncze sygnały - 11.08.2018   IAIN nr C.I.z

Lenograstim [313]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Lenwatynib [186] Pojedyncze sygnały   22.01.2022   IAIN nr C.I.z

Lenograstim [314]

Stanowisko CMDh - 01/11/2017   IAIN nr C.I.3 a)

Lenograstym, lipegfilgrastym, pegfilgrastym [40]

Pojedyncze sygnały - 11.08.2018   IAIN nr C.I.z

Letrozole [315]

Stanowisko CMDh

-

04/10/2017

 

IAIN nr C.I.3 a)

Leuprorelin [316] Stanowisko CMDh - 08/08/2018   IAIN nr C.I.3 a)

Levetiracetam (oral solution) [317]

Pojedyncze sygnały

-

25/12/2016

 

IAIN nr C.I.z

Levobunolol (dotyczy tylko wskazań okulistycznych) [318]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)

Levobupivacaine [319]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Levocetirizine [320]

PSUR worksharing

-

-

 
IB nr C.I.3 z)

Levocetirizine [321]

Stanowisko CMDh - 04/07/2018   IAIN nr C.I.3 a)
Levofloxacin  Decyzja Komisji Europejskiej art. 31   12/03/2019

IAIN nr C.I.1 a)/

IB nr C.I.1 b)

Levonorgestrel [322]

Stanowisko CMDh - 02/01/2019   IAIN nr C.I.3 a)

Levosimendan [323]

PSUR worksharing

-

-

 

 IB nr C.I.3 z)

Lewodopa [142]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Lidocaine hydrochloride [324]

Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian
Lisdeksmetamina [283] Pojedyncze sygnały   03/10/2020   IAIN nr C.I.z
Lomefloxacin  Decyzja Komisji Europejskiej art. 31   12/03/2019

IAINnr C.I.1 a)/

IB nr C.I.1 b)

Lomustine [325]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Loratidine [326]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Lorazepam [327]

Stanowisko CMDh - 30/01/2019   IAIN nr C.I.3 a)

Lormetazepam [328]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Loperamide [329]

Pojedyncze sygnały

-

04/06/2017

 

IAIN nr C.I.z

Losartan + Hydrochlorothiazide [330]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Lovastatin [331]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Lubiprostone [332]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Lymecycline [333]

Pediatryczny worksharing Art. 45 
Rozp. 1901/2006
01/04/2018* 
01/05/2018**
  IB nr C.I.3 z)

Macrogol 4000 [334]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Macrogol 4000 and combinations [335]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Magnesium hydroxide [336]

Stanowisko CMDh - 01/11/2017   IAIN nr C.I.3 a)
Magnesium valproate Decyzja Komisji Europejskiej Art. 31 - 01/06/2018 IB nr C.I.1 a) +
+ IAIN nr C.I.11 a) lub

IB nr C.I.1 b) +
+ IAIN nr C.I.11 a)

Mefloquine [337]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Mefloquine [338]

Stanowisko CMDh - 21/02/2018   IAIN nr C.I.3 a)

Meloxicam [339]

Stanowisko CMDh

-

05/07/2017

 

IAIN nr C.I.3 a)

Mepivacaine, mepivacaine/adrenaline, mepivacaine hydrochloride/dextrose monohydrate [340]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Merkaptopuryna [14]

Pojedyncze sygnały

-

11/06/2016

 

IAIN nr C.I.z

Meropenem (solutions for infusion) [33]

Pojedyncze sygnały

 

07/11/2017

 

IAIN nr C.I.z

Meropenem [341]

Stanowisko CMDh

-

10/08/2016

 

IAIN nr C.I.3 a)

Mesalazine [342]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Mesalazyna [343]

Pojedyncze sygnały

- 25/11/2017   IAIN nr C.I.z
Metamizole sodium Decyzja Komisji Europejskiej art. 31   20/03/2019

IAINnr C.I.1 a)/

IB nr C.I.1 b)

Methylaminolevulinate [344]

Stanowisko CMDh - 04/07/2018   IAIN nr C.I.3 a)

Methoxy polyethylene glycol-epoetin beta [33]

Pojedyncze sygnały

 

07/10/2017

 

IAIN nr C.I.z

Methyl salicylate /levomenthol [345]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Methyl salicylate /levomenthol /DL-camphor [346]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Methylphenidate [6]

Pojedyncze sygnały

 

03/03/2017

 

IAIN nr C.I.z

Methylphenidate hydrochloride [347]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Methylprednisolone [348]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Methylprednisolone (intravenous/intramuscular use) [349]

Stanowisko CMDh

Art. 31

29/09/2017

 

IB nr C.I.1 a) lub IB nr C.I.1 b)

Metoclopramide [350]

Stanowisko CMDh

-

05/10/2016

 

IAIN nr C.I.3 a)

Metotreksat [174]

Pojedyncze sygnały - 05.04.2018   IAIN nr C.I.z
Metotreksat [351] Pojedyncze sygnały - 30.11.2021   IAIN nr C.I.z

Metronidazole [317]

Pojedyncze sygnały

 

25/12/2016

 

IAIN nr C.I.z

Miconazole / Hydrocortisone, miconazole nitrate /Miconazole nitrate, zinc oxide [352]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Mifepristone /misoprostol [353]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)

Milnacipran [354]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Milnacipran [355]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Minoxidil (topical fprmulation) [356]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Mirtazapine [357]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Misoprostol (gastrointestinal indication) [358]

Stanowisko CMDh - 06/06/2018   IAIN nr C.I.3 a)

Misoprostol (gynaecological indication - labour induction) [359]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Misoprostol (gynaecological indication) [360]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Misoprostol (gynaecological indication –termination of pregnancy) [361]

Stanowisko CMDh - 09/05/2018   IAIN nr C.I.3 a)
Mirtazapina [57] Pojedyncze sygnały   23/08/2020   IAIN nr C.I.z

Mizolastine [362]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)

Moclobemide [363]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Modafinil [364]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Mometasone+salicylic acid [365]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Morphine, 
morphine / cyclizine
[366]

Stanowisko CMDh - 10/10/2018 - IAIN nr C.I.3 a)
Moxifloxacin korekta Decyzji Komisji Europejskiej art. 31   12/03/2019 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Moxifloxacin (systemic use) [367]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Mycophenolic acid [368]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Nabumetone [369]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

N-acetyl-aspartyl-glutamic acid [370]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Nadifloxacin [371]

Stanowisko CMDh

 

10/05/2017

 

IAIN nr C.I.3 a)

Nadroparin [372]

Stanowisko CMDh - 27/03/2019   IAIN nr C.I.3 a)

Nafarelin [373]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Naloxone [374]

PSUR worksharing - - - Bez konieczności złożenia zmian
Naproxen [375] Stanowisko CMDh - 08/08/2018   IAIN nr C.I.3 a)

Natalizumab [376]

Pojedyncze sygnały

-

06/08/2016

 

IAIN nr C.I.z

Natalizumab [211]

Pojedyncze sygnały

-

01/08/2015

 

IAIN nr C.I.z

Nebivolol [377]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Nedocromil [378]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Nefopam [379]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Nicardipine [380]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Nicardipine hydrochloride [381]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Nifedipine [382]

Stanowisko CMDh

-

10/08/2016

 

IAIN nr C.I.3 a)

Nifuroxazide [383]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Nilotynib [142]

Pojedyncze sygnały

-

07/05/2016

 

IAIN nr C.I.z

Nitrofurantoin, Nifurtoinol [384]

Stanowisko CMDh - 27/02/2019   IAIN nr C.I.3 a)

Nitrous oxide, nitrous oxide / oxygen [385]

Stanowisko CMDh - 06/06/2018   IAIN nr C.I.3 a)

Nilvadipine [386]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Nivolumab [329]

Pojedyncze sygnały

-

04/06/2017

 

IAIN nr C.I.z

Nivolumab [215]

Pojedyncze sygnały

-

06/05/2017

 

IAIN nr C.I.z

Niwolumab [282]

Pojedyncze sygnały   06/06/2020   IAIN nr C.I.z

Nivolumab [387]

Pojedyncze sygnały   10/05/2020   IAIN nr C.I.z

Nomegestrol [388]

Stanowisko CMDh - 30/01/2019   IAIN nr C.I.3 a)
Norfloxacin  Decyzja Komisji Europejskiej art. 31   12/03/2019

IAINnr C.I.1 a)/

IB nr C.I.1 b)

Nortriptyline [389]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Norepinefryna [99]

Pojedyncze sygnały  - 03.06.2018   IAIN nr C.I.z
Octenidine dihydrochloride, phenoxyethanol [390] Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)

Octreotide [391]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ofloxacin [392]

PSUR worksharing

-

-

 

 IB nr C.I.3 z)

ofloxacin Decyzja Komisji Europejskiej art. 31   12/03/2019

IAIN nr C.I.1 a)/

IB nr C.I.1 b)

Ofloxacin (systemic use) [393]

Stanowisko CMDh

-

30/03/2016

 

IAIN nr C.I.3 a)

Ofloxacin (topical use) [394]

Stanowisko CMDh

-

30/03/2016

 

IAIN nr C.I.3 a)

Olanzapine [59]

Pojedyncze sygnały

-

21/01/2017

 

IAIN nr C.I.z

Olanzapine [395]

Pojedyncze sygnały

-

10/07/2016

 

IAIN nr C.I.z

Oksybutynina [396]

Pojedyncze sygnały

-

08/04/2016

 

IAIN nr C.I.z

Ombitasvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Omega-3-acid-ethyl esters [397]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Omeprazole [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Omeprazole [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Omeprazol [143]

Pojedyncze sygnały

-

07/11/2015

 

IAIN nr C.I.z

Ondansetron [398]

Stanowisko CMDh

-

03/02/2016

 

IAIN nr C.I.3 a)

Oxaliplatin [399]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Oxaliplatin [400]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Oxaliplatin [401]

Stanowisko CMDh   27/03/2019   IAIN nr C.I.3 a)

Oxatomide [402]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Oxcarbazepine [403]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Oxybutynin hydrochloride [404]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Oxytetracycline [405]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Ozenoxacin [406]

PSUR worksharing   Nie dotyczy   Bez konieczności złożenia zmian

Oxytocin [407]

Stanowisko CMDh - 04/07/2018   IAIN nr C.I.3 a)

Quinine [408]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)

Paclitaxel [409]

Stanowisko CMDh

-

18/12/2016

 

IAIN nr C.I.3 a)

Paclitaxel [410]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Pamidronate [411]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Pantoprazole [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Pantoprazole [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Pantoprazol [143]

Pojedyncze sygnały

-

07/11/2015

 

IAIN nr C.I.z

Paracetamol / Tramadol [412]

Stanowisko CMDh

-

14/07/2016

 

IAIN nr C.I.3 a)

Paracetamol/Tramadol [413]

PSUR worksharing

-

11/09/2016

 

IB nr C.I.3 z)

Paracetamol for infusion [414]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Paricalcitol [415]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Pariet (rabeprazole sodium) [416]

Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Paritaprevir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Paroxetine [417]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Paroxetine [418]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)
Paroksetyna [282] Pojedyncze sygnały   06/06/2020   IAIN nr C.I.z
Pefloxacin Decyzja Komisji Europejskiej art. 31   12/03/2019

IAIN nr C.I.1 a)/

IB nr C.I.1 b)

Peginterferon alfa-2a [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Peginterferon alfa-2b [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Peginterferon beta-1a [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Pembrolizumab [329]

Pojedyncze sygnały

-

04/06/2017

 

IAIN nr C.I.z

Pembrolizumab [40]

Pojedyncze sygnały - 11.08.2018   IAIN nr C.I.z
Pembrolizumab [124] Pojedyncze sygnały   26.12.2020   IAIN nr C.I.z
Pembrolizumab [112] Pojedyncze sygnały   06.03.2021   IAIN nr C.I.z

Pemetreksed  [174]

Pojedyncze sygnały - 05.04.2018   IAIN nr C.I.z

Penciclovir (topical use only) [419]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Perindopril [420]

Stanowisko CMDh

-

05/10/2016

 

IAIN nr C.I.3 a)

Permethrin [421] Stanowisko CMDh   08/08/2018   IAIN nr C.I.3 a)

Perphenazine [28]

Stanowisko CMDh

-

03/02/2016

 

IAIN nr C.I.3 a)

Phenindione [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Phenprocoumon [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Phenylephrine [422]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Pimecrolimus [423]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Piperacylina; piperacylina z tazobaktamem [134]

Pojedyncze sygnały   26.12.2021   IAIN nr C.I.z

Piretanide [424]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ponatynib [351] Pojedyncze sygnały - 30.11.2021   IAIN nr C.I.z

Pramiracetam [425]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Pramipeksol [343]

Pojedyncze sygnały

- 25/11/2017   IAIN nr C.I.z

Pravastatin [426]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Pravastatin sodium + buffered aspirin [427]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Praziquantel [428]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Prednisolone [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Prednisone [33]

Pojedyncze sygnały

-

07/10/2017

 

IAIN nr C.I.z

Prednizolon; prednizon (o działaniu ogólnoustrojowym) [429]

Pojedyncze sygnały   08/05/2021   IAIN nr C.I.z
Pregabalina [175] Pojedyncze sygnały   07.04.2022   IAIN nr C.I.z
Priorix (measles, mumps and rubella vaccine)  [430]
DE/W/0055/pdWS/005 [430]
Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Priorix (measles, mumps and rubella vaccine)
DE/W/0055/pdWS/003
[431]

Pediatryczny worksharing

Art. 46
Rozp. 1901/2006

Nie dotyczy   Bez konieczności złożenia zmian
Priorix (measles, mumps and rubella vaccine) [432]
DE/W/0055/pdWS/006 [432]
Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Procyanidolic oligomers [433]

PSUR worksharing - 13/08/2018   IB nr C.I.3 z)
Produkty zawierające makrogol (wszystkie masy cząsteczkowe i skojarzenia) do oczyszczania jelita [158] Pojedyncze sygnały   06/09/2020   IAIN nr C.I.z

Promestriene (cream and vaginal capsules) [434]

Stanowisko CMDh - 21/02/2018   IAIN nr C.I.3 a)

Propofol [51]

Pojedyncze sygnały

-

06/04/2017

 

IAIN nr C.I.z

Propofol [435]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Propofol [436]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)

Prulifloxacin [437]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Prulifloxacin [438]

Stanowisko CMDh   10/10/2018   IAIN nr C.I.3 a)
Prulifloxacin Decyzja Komisji Europejskiej art. 31   12/03/2019

IAIN nr C.I.1 a)/

IB nr C.I.1 b)

Quetiapine fumarate [439]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Rabbit anti-human thymocyte (powder for solution for infusion) [440]

Stanowisko CMDh

-

04/11/2015

 

IAIN nr C.I.3 a)

Rabbit anti-human thymocyte immunoglobulin [441]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Rabeprazole [6]

Pojedyncze sygnały

-

03/04/2017

 

IAIN nr C.I.z

Rabeprazole [153]

Pojedyncze sygnały

-

02/11/2016

 

IAIN nr C.I.z

Rabeprazol [143]

Pojedyncze sygnały

-

07/11/2015

 

IAIN nr C.I.z

Rabeprazole [442]

Stanowisko CMDh

-

04/10/2017

 

IAIN nr C.I.3 a)

Rabies vaccine [443]

Stanowisko CMDh

-

22/02/2017

 

IAIN nr C.I.3 a)

Ramipril [444]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ranitidine [445]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Recombinant human interferon gamma-1b [446]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Remifentanil [447]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Retinoids (acitretin, alitretinoin, isotretinoin) - doustne

Decyzja Komisji Europejskiej art. 31   22/06/2018 IB nr C.I.1 a) +
+ IAIN nr C.I.11 a)

Retinoids (acitretin,  bexarotene, tretinoin )- doustne

Decyzja Komisji Europejskiej art. 31   22/06/2018 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Retinoids (alitretinoin,  isotretinoin) -  doustne

Decyzja Komisji Europejskiej art. 31   22/06/2018 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Retinoids (adapalene, alitretinoin, isotretinoin, tazarotene, tretinoin) - stosowane miejscowo

Decyzja Komisji Europejskiej art. 31   22/06/2018 IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Riociguat [448]

Pojedyncze sygnały

-

03/08/2016

 

IAIN nr C.I.z

Rilmenidine [449]

Stanowisko CMDh

-

10/08/2016

 

IAIN nr C.I.3 a)

Risperidone [450]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ritonavir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Rizatriptan benzoate [451]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ropinirole [452]

Stanowisko CMDh

-

05/07/2017

 

IAIN nr C.I.3 a)

Ropivacaine [453]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Rosuvastatin [454]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)

Roxithromycin [455]

Stanowisko CMDh - 27/12/2017   IAIN nr C.I.3 a)
Rufloxacin  Decyzja Komisji Europejskiej art. 31   12/03/2019

IAINnr C.I.1 a)/

IB nr C.I.1 b)

Rupatadine [456]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Rupatadine fumarate [457]

PSUR worksharing

-

-

 

 IB nr C.I.3 z)

Rytonawir; lopinawir; rytonawir; ombitaswir; parytaprewir; rytonawir; lewotyroksyna [207]

Pojedyncze sygnały  - 05.05.2018   IAIN nr C.I.z

Sabrilex (vigabatrin) [458]

Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Saccharomyces boulardii [459]

Stanowisko CMDh - 24/01/2018   IAIN nr C.I.3 a)

Sativex (delta-9-tetrahydrocannabinol and cannabidiol) [460]

Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
02/11/2018* 
03/12/2018**
  IB nr C.I.3 z)
Sekukinumab [18] Pojedyncze sygnały   31/07/2021   IAIN nr C.I.z
Sertalina [57] Pojedyncze sygnały   23/08/2020   IAIN nr C.I.z
 

R worksharing

-

-

 

IB nr C.I.3 z)

Seretide Evohaler and related names (fluticasone propionate/salmeterol xinafoate) [461] Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
24/11/2018*
24/12/2018**
   IB nr C.I.3 z)

Simeprevir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Simvastatin [462]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Simvastatin [463]

Stanowisko CMDh   28/03/2018   IAIN nr C.I.3 a)

Sodium iodine (123I) [464]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Sodium valproate [89]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Sodium valproate Decyzja Komisji Europejskiej Art. 31 - 01/06/2018
IB nr C.I.1 a) +
+ IAIN nr C.I.11 a) lub

IB nr C.I.1 b) +
+ IAIN nr C.I.11 a)

Sodium iodide (131i) [465]

Stanowisko CMDh - 21/02/2018   IAIN nr C.I.3 a)

Sofosbuvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Sofosbuwir [138]

Pojedyncze sygnały

-

13/06/2015

 

IAIN nr C.I.z

Solifenacin [466]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Solifenacin/tamsulosin [467]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Spikevax [134] Pojedyncze sygnały   01.11.2021   IAIN nr C.I.z

Spironolactone [468]

Stanowisko CMDh

-

02/03/2016

 

IAIN nr C.I.3 a)

Standardised allergen extract from house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farina) [469]

PSUR worksharing - 02/03/2018   IB nr C.I.3 z)

Strontium (89Sr) Chloride [470]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Sulfametoksazol, trimetoprym (kotrimoksazol) [18] Pojedyncze sygnały   31/07/2021   IAIN nr C.I.z

Sufentanil citrate [471]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Sulbactam [472]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Sulprostone [473]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Sulproston [474]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Szczepionka mRNA przeciw COVID-19 (ze zmodyfikowanymi nukleozydami) (Comirnaty) [18] Pojedyncze sygnały   14/06/2021   IAIN nr C.I.z
Szczepionka przeciwko COVID-19 (ChAdOx1-S [rekombinowana]) (szczepionka AstraZeneca przeciwko COVID-19) [37] Pojedyncze sygnały   20/04/2021   IAIN nr C.I.z

Tapentadol [475]

Stanowisko CMDh   07/11/2018   IAIN nr C.I.3 a)

Tacrolimus [306]

Pojedyncze sygnały

-

26.02.2019

 

IAIN nr C.I.z

Technetium (99mTc) [476]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Technetium (99mTc) exametazime [477]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Technetium (Tc-99m) bicisate [478]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Technetium (99mtc) mebrofenin [479]

Stanowisko CMDh

-

02/11/2016

 

IAIN nr C.I.3 a)

Temozolomide [15]

Pojedyncze sygnały

-

02/07/2017

 

IAIN nr C.I.z

Tenoxicam [480]

Stanowisko CMDh

-

03/03/2016

 

IAIN nr C.I.3 a)

Teriflunomide [15]

Pojedyncze sygnały

-

02/07/2017

 

IAIN nr C.I.z

Teryflunomid [166]

Pojedyncze sygnały  

29.12.2018

 

IAIN nr C.I.z

Testosterone [481]

Stanowisko CMDh

Art. 31

20/02/2015

 

IB nr C.I.1 a) lub IB nr C.I.1 b)

Testosterone (all formulations apart from topical use and testosterone undecanoate injection) [482]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Testosterone (topical use) [483]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Testosterone undecanoate (injection) [484]

Stanowisko CMDh

-

28/12/2016

 

IAIN nr C.I.3 a)

Testosterone undecylate (injection) [485]

Stanowisko CMDh

-

04/11/2015

 

IAIN nr C.I.3 a)

Tetrabenazine [486]

Stanowisko CMDh

-

07/10/2015

 

IAIN nr C.I.3 a)

Thiocolchicoside [487]

Stanowisko CMDh

-

30/06/2016

 

IAIN nr C.I.3 a)

Thiopental [488]

Stanowisko CMDh

-

29/03/2017

 

IAIN nr C.I.3 a)

Tiagabine (hydrochloride) [489]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Tianeptine [490]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Tiapride [491]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Tiazydy, leki moczopędne o strukturze zbliżonej do tiazydów i połączenia z nimi [282] Pojedyncze sygnały   06/06/2020   IAIN nr C.I.z

Tibolone [492]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Tick-borne encephalitis vaccine (inactivated) [493]

PSUR worksharing

-

-

 

 IB nr C.I.3 z)

Ticlopidine [494]

Stanowisko CMDh

-

11/05/2016

 

IAIN nr C.I.3 a)

Tinidazole [495]

Pediatryczny worksharing Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Tioconazole [496]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Tirofiban hydrochloride [497]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Ticarcillin and clavulanic acid [498]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Tixocortol, Tixocortol/Chlorhexidine [499]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Tixocortol chlorhexidine gluconate / tixocortol pivalate [500] Stanowisko CMDh - 01/11/2017   IAIN nr C.I.3 a)

Tizanidine [501]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Tobi/Tobi Podhaler (tobramycin) 
UK/W/0089/pdWS/003
[502]

Pediatryczny worksharing Art. 46 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Tolterodine [503]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Trabektedyna [117]

Pojedyncze sygnały

-

06/12/2015

 

IAIN nr C.I.z

Trabektedyna [138]

Pojedyncze sygnały

-

13/07/2015

 

IAIN nr C.I.z

Tramadol [504]

Stanowisko CMDh - 11/05/2018   IAIN nr C.I.3 a)
Tramadol; tramadol, deksketoprofen; tramadol, paracetamol [18] Pojedyncze sygnały   31/07/2021   IAIN nr C.I.z

Trandolapril + Verapamil [505]

Stanowisko CMDh

-

02/03/2016

 

IAIN nr C.I.3 a)

Trandolapril + Verapamil [506]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Treprostinil [507]

Stanowisko CMDh

-

10/05/2017

 

IAIN nr C.I.3 a)

Treprostinil [508]

Stanowisko CMDh - 10/10/2018   IAIN nr C.I.3 a)

Triamcinolone acetonide [509]

Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
03/12/2018* 
31/12/2018**
  IB nr C.I.3 z)

Triamcinolone (intraocular formulations) [510]

Stanowisko CMDh

-

24/02/2017

 

IAIN nr C.I.3 a)

Trileptal (Oxcarbazepine) [511]

Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
28/12/2018* 
27/01/2019**
  IB nr C.I.3 z)

Trimetazidine [512]

Stanowisko CMDh

-

05/07/2017

 

IAIN nr C.I.3 a)

Tropicamide [513] Pediatryczny worksharing
Art. 45 
Rozp. 1901/2006
Nie dotyczy   Bez konieczności złożenia zmian

Tybolon [54]

Pojedyncze sygnały

-

06/04/2016

 

IAIN nr C.I.z

Tygecyklina [14]

Pojedyncze sygnały

-

11/06/2016

 

IAIN nr C.I.z

Typhim Vi (Salmonella Typhimurium) [514]

Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
02/11/2018* 
03/12/2018**
  IB nr C.I.3 z)
Warfaryna [134] Pojedyncze sygnały   26.12.2021   IAIN nr C.I.z

 Valaciclovir [515]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Valproate [516]

Stanowisko CMDh

Art. 31

-

 

  IB nr C.I.3 z)

Valproate Decyzja Komisji Europejskiej Art. 31 - 01/06/2018
IB nr C.I.1 a) +
+ IAIN nr C.I.11 a) lub
IB nr C.I.1 b) +
+ IAIN nr C.I.11 a)

Valproate bismuth [89]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Valproate magnesium [89]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Valproate pivoxil [89]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Valproate semisodium [89]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Valproate semisodium Decyzja Komisji Europejskiej Art. 31 01/06/2018  
IB nr C.I.1 a) +
+ IAIN nr C.I.11 a) lub

IB nr C.I.1 b) +
+ IAIN nr C.I.11 a)

Valproic acid [89]

Stanowisko CMDh

-

06/01/2016

 

IAIN nr C.I.3 a)

Valproic acid Decyzja Komisji Europejskiej Art. 31 - 01/06/2018
IB nr C.I.1 a) +
+ IAIN nr C.I.11 a) lub

IB nr C.I.1 b) +
+ IAIN nr C.I.11 a)
Valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpriomide, valproate bismuth, calcium valproate, valproate magnesium [517] Stanowisko CMDh -
02/01/2019
  IAIN nr C.I.3 a)

Valpromide [89]

Stanowisko CMDh

-

   06/01/2016

 

IAIN nr C.I.3 a)

Valpromide Decyzja Komisji Europejskiej Art. 31 - 01/06/2018
IB nr C.I.1 a) +
+ IAIN nr C.I.11 a) lub

IB nr C.I.1 b) +
+ IAIN nr C.I.11 a)

Valsartan [518]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Vancomycin

Decyzja Komisji Europejskiej art. 31 - 22.09.2017 r. IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Vancomycin

korekta Decyzji Komisji Europejskiej art. 31 - 17.11.2017 r. IAIN nr C.I.1 a)/
IB nr C.I.1 b)

Varicella Vaccine (live) [519]

PSUR worksharing

-

  -

 

IB nr C.I.3 z)

Vaxzevria [520] Pojedyncze sygnały   13.11.2021   IAIN nr C.I.z

Vecuronium bromide [521]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Velpatasvir [12]

Pojedyncze sygnały

-

26/11/2016

 

IAIN nr C.I.z

Venlafaxine [522]

PSUR worksharing - 18/02/2018   IB nr C.I.3 z)

Vildagliptin [6]

Pojedyncze sygnały

-

03/03/2017

 

IAIN nr C.I.z

Warfarin [376]

Pojedyncze sygnały

-

06/09/2016

 

IAIN nr C.I.z

Wortioksetyna [27]

Pojedyncze sygnały - 07.07.2018   IAIN nr C.I.z

Zafirlukast [523]

PSUR worksharing

-

-

 

IB nr C.I.3 z)

Zithromax (azithromycin (dehydrate)) [524] Pediatryczny worksharing
Art. 46 
Rozp. 1901/2006
15/03/2019*
14/04/2019**
  IB nr C.I.3 z)

 Zolmitriptan [525]

PSUR worksharing

-

-

 

   IB nr C.I.3 z)

Donepezil [526]

Pojedyncze sygnały

  02/10/2021   IAIN nr C.I.z
Inhibitory immunologicznych punktów kontrolnych: atezolizumab, awelumab, cemiplimab, durwalumab, ipilimumab, pembrolizumab, niwolumab [526] Pojedyncze sygnały   02/10/2021   IAIN nr C.I.z
Oktreotyd [526] Pojedyncze sygnały   02/10/2021   IAIN nr C.I.z
Szczepionka przeciwko COVID-19 (ChAdOx1-S [rekombinowana]) — Vaxzevria [527] Pojedyncze sygnały   29/06/2021   IAIN nr C.I.z
Ceftriakson [528] Pojedyncze sygnały   05/09/2021   IAIN nr C.I.z
Tofacytynib [528] Pojedyncze sygnały   05/09/2021   IAIN nr C.I.z
Olmesartan; olmesartan, amlodypina; olmesartan, hydrochlorotiazyd; olmesartan medoksomil, bezylan amlodypiny, hydrochlorotiazyd [529] Pojedyncze sygnały   06/03/2022   IAIN nr C.I.z

 * - termin złożenia zmiany dla podmiotu odpowiedzialnego, który składał dane oceniane w ramach procedury worksharing

** - termin złożenia zmiany dla pozostałych podmiotów odpowiedzialnych produktów leczniczych zawierających tę samą substancję czynną i postać farmaceutyczną


Źródłowy URL: https://urpl.gov.pl/pl/produkty-lecznicze/zalecenia-dla-podmiot%C3%B3w-odpowiedzialnych

Odnośniki
[1] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/17-alpha-oestradiol_topical_SAR_2017_02.pdf
[2] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214315.pdf
[3] https://www.ema.europa.eu/documents/psusa-conclusions/5-fluorouracil-iv-application-cmdh-scientific-conclusions-grounds-variation-amendments-product/00000007/201712_pl.pdf
[4] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Technetium_99mTc_macrosalb_SAR_2014_04.pdf
[5] https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-13-16-january-2020_pl.pdf
[6] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/01/WC500219294.pdf
[7] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/10/WC500237199.pdf
[8] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Acetylsalicylic_acid_Art.45_PAR_2018_04.pdf
[9] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/08/WC500211852.pdf
[10] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-11-14-january-2021_pl.pdf
[11] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/07/WC500251941.pdf
[12] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/09/WC500213124.pdf
[13] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Salmeterol_xinafoate_fluticasone_propionate_2018_09.pdf
[14] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/04/WC500204647.pdf
[15] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/05/WC500226577.pdf
[16] https://www.ema.europa.eu/documents/psusa-conclusions/aldesleukin-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00000076/201712_pl.pdf
[17] https://www.ema.europa.eu/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-3-6-september-2018_pl.pdf
[18] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-3-6-may-2021-prac_pl.pdf
[19] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237281.pdf
[20] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/11/WC500216582.pdf
[21] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/06/WC500249950.pdf
[22] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245238.pdf
[23] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214408.pdf
[24] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214409.pdf
[25] https://www.ema.europa.eu/documents/psusa-conclusions/amantadine-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00000126/201801_pl.pdf
[26] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214414.pdf
[27] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/05/WC500248801.pdf
[28] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214412.pdf
[29] https://www.ema.europa.eu/documents/psusa-conclusions/amitriptyline-amitriptyline/amitriptylinoxide-amitriptylinoxide-cmdh-scientific-conclusions-grounds-variation-amendments-product/00010374/201801_pl.pdf
[30] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500238792.pdf
[31] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Amlodipine_Atorvastatine_SAR_2016_05.pdf
[32] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214415.pdf
[33] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/08/WC500233098.pdf
[34] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Amphotericin_B_Art.45_PAR_2018_04.pdf
[35] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214457.pdf
[36] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2015/11/WC500196278.pdf
[37] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-8-11-march-2021-prac_pl.pdf
[38] https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-14-17-april-2020-prac_en.pdf
[39] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215087.pdf
[40] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2018/06/WC500250488.pdf
[41] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214462.pdf
[42] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214460.pdf
[43] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214464.pdf
[44] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Asmanex_Twisthaler_02_2018_Art._46_PAR.pdf
[45] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214467.pdf
[46] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214469.pdf
[47] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Atorvastatin_SAR_2017_08.pdf
[48] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500253901.pdf
[49] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Atovaquone_and_proguanil_hydrochloride_2018_09.pdf
[50] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Atracurium_SmAR_10_2017.pdf
[51] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/02/WC500220973.pdf
[52] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-6-9-april-2021-prac_pl.pdf
[53] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/02/WC500244579.pdf
[54] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/01/WC500199438.pdf
[55] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237770.pdf
[56] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/07/WC500231714.pdf
[57] https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-11-14-may-2020-prac_pl.pdf
[58] https://www.ema.europa.eu/documents/psusa/bcg-vaccine-freeze-dried-cmdh-scientific-conclusions-grounds-variation-amendments-product/00000304/201803_pl.pdf
[59] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/11/WC500216685.pdf
[60] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214625.pdf
[61] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214627.pdf
[62] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/11/WC500215651.pdf
[63] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237255.pdf
[64] https://www.ema.europa.eu/documents/psusa-conclusions/bendroflumethiazide-bendroflumethiazide/potassium-chloride-cmdh-scientific-conclusions-grounds-variation-amendments-product-information_pl.pdf
[65] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214629.pdf
[66] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Berinert_Art.46_12_2018.pdf
[67] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/11/WC500216759.pdf
[68] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500238822.pdf
[69] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214635.pdf
[70] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245121.pdf
[71] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214891.pdf
[72] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215206.pdf
[73] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215393.pdf
[74] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/05/WC500228459.pdf
[75] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Bromazepam_SAR_10_2017.pdf
[76] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Brotizolam_SAR_2014_09.pdf
[77] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500223322.pdf
[78] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Budesonide_SAR_2016_08.pdf
[79] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/budesonide_formoterol.pdf
[80] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Buflomedil_hydrochloride_PSUR_SAR.pdf
[81] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Bumetanide_2018_09.pdf
[82] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/PSUR_WS_buprenorphine_2016_12.pdf
[83] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/11/WC500216617.pdf
[84] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Cabergoline_PSUR_SAR_2016_02.pdf
[85] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/07/WC500251988.pdf
[86] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214649.pdf
[87] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/calcium_carbonate_colecalciferol.pdf
[88] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Calcium_chloride_dihydrate_etc_SaR_2018_06.pdf
[89] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214325.pdf
[90] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Candesartan_SAR_2014_09.pdf
[91] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245041.pdf
[92] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/01/WC500220336.pdf
[93] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/captopril__hydrochlorothiazide_PSUR_SAR.pdf
[94] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/11/WC500216557.pdf
[95] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/08/WC500233059.pdf
[96] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214655.pdf
[97] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Carteolol_SAR_2015_02.pdf
[98] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500248033.pdf
[99] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2018/04/WC500246649.pdf
[100] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/cefepime_SAR_2015_10.pdf
[101] https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-26-29-october-2020_pl.pdf
[102] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215422.pdf
[103] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215180.pdf
[104] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Cefotaxime_SAR_2014_01.pdf
[105] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500242436.pdf
[106] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ceftazidime_2015_01.pdf
[107] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Certican_02_2018_Art._46_PdAR.pdf
[108] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Cetirizine_SAR_2014_02.pdf
[109] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2017/06/WC500230337.pdf
[110] https://www.ema.europa.eu/documents/psusa-conclusions/cisplatin-cmdh-scientific-conclusions-amendments-product-information-implementation-timetable-psusa/00000778/201712_pl.pdf
[111] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/12/WC500240068.pdf
[112] https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-23-26-november-2020_pl.pdf
[113] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214664.pdf
[114] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/07/WC500230459.pdf
[115] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/PSUR_WS_chlorpromazine_2016_12.pdf
[116] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/chlorprothixene_hydrochloride_SAR_2014_06.pdf
[117] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2015/10/WC500195097.pdf
[118] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ciclopirox__shampoo_only__SmAR_2018_04.pdf
[119] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ciclosporin_SAR_2013_11.pdf
[120] https://www.ema.europa.eu/documents/psusa/cilazapril-cilazapril/hydrochlorothiazide-cmdh-scientific-conclusions-grounds-variation-amendments-product-information_pl.pdf
[121] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214670.pdf
[122] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ciprofloxacin_SAR_2015_09.pdf
[123] https://www.ema.europa.eu/documents/psusa/ciprofloxacin-systemic-use-cmdh-scientific-conclusions-grounds-variation-amendments-product/00000775/201801_pl.pdf
[124] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-28-september-1-october_pl.pdf
[125] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ciprofloxacin_dexamethason_SAR_2015_11.pdf
[126] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Clarithromycin_SAR_2016_05.pdf
[127] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/02/WC500243557.pdf
[128] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Clebopride_PSUR_SAR.pdf
[129] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Clevidipine_Summary_AR_2015_05.pdf
[130] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Clodronate_SAR_2014_04.pdf
[131] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Clostridium_botulinum_neurotoxin_type_A_haemagglutinin_complex_PSUR_SAR.pdf
[132] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Clostridium_botulinum_toxin_05_2018.pdf
[133] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeine_containing_medicinal_products_for_the_treatment_of_cough_and_cold_in_paediatric_patients/human_referral_prac_000039.jsp&mid=WC0b01ac05805c516f
[134] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-part-2-adopted-27-30-september_pl.pdf
[135] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214383.pdf
[136] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214385.pdf
[137] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/cyproterone_acetate___ethinylestradiol_SAR_2015_10.pdf
[138] http://www.ema.europa.eu/docs/pl_PL/document_library/PRAC_recommendation_on_signal/2015/05/WC500186846.pdf
[139] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Danaparoid_SAR_2014_10.pdf
[140] https://www.ema.europa.eu/documents/psusa-conclusions/dapoxetine-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable_pl.pdf
[141] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214390.pdf
[142] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/03/WC500202894.pdf
[143] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2015/08/WC500191719.pdf
[144] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214392.pdf
[145] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500247840.pdf
[146] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Deoxicholic_acid_SAR_2017_11.pdf
[147] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500253939.pdf
[148] https://www.ema.europa.eu/documents/psusa/deoxycholic-acid-cmdh-scientific-conclusions-grounds-variation-amendments-product-information/00010525/201804_pl.pdf
[149] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Deoxyribonuclease_human_dirnase_alpha_SAR_2016_03.pdf
[150] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/desogestrel_SAR_2014_07.pdf
[151] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/11/WC500217416.pdf
[152] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/06/WC500250513.pdf
[153] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/08/WC500211453.pdf
[154] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500237938.pdf
[155] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Dexibuprofen_Summary_AR_2015_05.pdf
[156] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Dexketoprofen_SAR_2013_11.pdf
[157] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214438.pdf
[158] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-8-11-june-2020-prac_pl.pdf
[159] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237355.pdf
[160] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500248111.pdf
[161] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214441.pdf
[162] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Didanosine_PSUR_SAR_2015_12.pdf
[163] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Dinoprostone_2014_11.pdf
[164] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Diovan_Angiosan_Valsartan_Novartis__valsartan_-_Art._46_PAR.pdf
[165] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Valsartan_Art_46_PAR_12_2017.pdf
[166] https://www.ema.europa.eu/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-october-2018-prac_pl.pdf
[167] https://urpl.gov.pl/sites/default/files/zalaczniki/WC500234300.pdf
[168] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/12/WC500218958.pdf
[169] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/dorzolamide__timolol.pdf
[170] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214761.pdf
[171] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/doxylamine_PSUR_SAR.pdf
[172] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Doxycycline_02_2018_Art._45_PAR_.pdf
[173] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Drospirenone__ethinylestradiol_SAR_2014_10.pdf
[174] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/02/WC500243151.pdf
[175] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-10-13-january-2022_pl.pdf
[176] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/dutasteride_SAR_2014_06.pdf
[177] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ebastine_SAR_2015_06.pdf
[178] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Econazole-econazole_combinations_SAR_2013_11.pdf
[179] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Enalapril_SAR_2014_02.pdf
[180] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500253968.pdf
[181] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/epinastine_hydrochloride_SAR_2014_07.pdf
[182] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Epirubicin_PSUR_SAR_2015_12.pdf
[183] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500242142.pdf
[184] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Eprosartan_hydrochlorothiazide_November_2017.pdf
[185] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Eprosartan_November_2017.pdf
[186] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-25-28-october-2021_pl.pdf
[187] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Erythromycin_2018_09.pdf
[188] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/estradiol_dienogest_SAR_2014_05.pdf
[189] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Estradiol_norethisterone_SAR_2014_09.pdf
[190] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ethinylestradiol_dienogest.pdf
[191] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ethinylestradiol_levonorgestrel_SAR_2016_04.pdf
[192] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500238503.pdf
[193] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Etomidate_PSUR_SmAR_July_2017.pdf
[194] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/07/WC500251918.pdf
[195] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214647.pdf
[196] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ezetimibe_SAR_2015_06.pdf
[197] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/05/WC500248462.pdf
[198] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ezetimibe__simvastatin_SAR_01_2018.pdf
[199] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214674.pdf
[200] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/07/WC500251965.pdf
[201] https://urpl.gov.pl/sites/default/files/zalaczniki/WC500234898.pdf
[202] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/felodipine___ramipril_SAR_2014_06.pdf
[203] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/fenoterol_hydrobromide-ipratropium_bromide_SAR_2014_06.pdf
[204] https://www.ema.europa.eu/documents/psusa/fenspiride-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00001368/201804_pl.pdf
[205] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/fentanyl_SAR_2015_10.pdf
[206] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ferumoxsil_SAR_2014_05.pdf
[207] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2018/03/WC500244960.pdf
[208] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/finasteride_SAR_2015_09.pdf
[209] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/05/WC500228684.pdf
[210] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/06/WC500250190.pdf
[211] http://www.ema.europa.eu/docs/pl_PL/document_library/PRAC_recommendation_on_signal/2015/06/WC500187420.pdf
[212] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Benzylnicotine_comb_SAR_2014_01.pdf
[213] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500238277.pdf
[214] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Fluconazole_Updated_SAR_2016_01.pdf
[215] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/03/WC500222392.pdf
[216] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Flumazenil_SAR_2014_04.pdf
[217] https://www.ema.europa.eu/documents/psusa/fluorodopa-18f-cmdh-scientific-conclusions-grounds-variation-amendments-product-information/00010002/201803_pl.pdf
[218] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Fluoxetine_SAR_2015_06.pdf
[219] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/fluticasone.pdf
[220] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500240862.pdf
[221] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Fluvoxamine_2018_03.pdf
[222] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/07/WC500251381.pdf
[223] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245044.pdf
[224] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Folinic_acid__di_sodium_folinate_calcium_folinate_PSUR_SAR_2015_12.pdf
[225] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/formoterol_PSUR_SAR.pdf
[226] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214614.pdf
[227] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214612.pdf
[228] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Fusidic_acid_SAR_2014_10.pdf
[229] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/11/WC500217363.pdf
[230] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/gabapentin_SAR_2015_10.pdf
[231] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/07/WC500230379.pdf
[232] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214692.pdf
[233] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214694.pdf
[234] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Gadodiamid_SAR_2014_02.pdf
[235] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214696.pdf
[236] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Gadopentetic_acid_PSUR_SAR_2015_12.pdf
[237] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214698.pdf
[238] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214700.pdf
[239] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214687.pdf
[240] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Gadoteridol_SAR_2014_02.pdf
[241] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214689.pdf
[242] https://www.ema.europa.eu/documents/psusa/gemcitabine-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00001519/201801_pl.pdf
[243] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500242435.pdf
[244] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Genotropin__somatropin__Art.46_PAR_2018_10.pdf
[245] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/03/WC500203290.pdf
[246] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Glatiramer_SAR_2014_01.pdf
[247] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214295.pdf
[248] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500242197.pdf
[249] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214298.pdf
[250] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/07/WC500209923.pdf
[251] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214300.pdf
[252] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/12/WC500219037.pdf
[253] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500239218.pdf
[254] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Havrix_Junior_720_Art._46_PAR_2018_10.pdf
[255] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Human_coagulation_factor_VII_SAR_2014_10.pdf
[256] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/human_coagulation_factor_VIII_SAR_2016_10.pdf
[257] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/human_coagulation_factor_VIII_inhibitor_SAR_2015_11.pdf
[258] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Human_fibirinogen_SmAR_09_2018.pdf
[259] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Humatrope_somatropin_Art.46_PAR_002_2018_04.pdf
[260] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Humatrope_somatropin_Art.46_PAR_003_2018_04.pdf
[261] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Humatrope_somatropin_Art.46_PAR_004_2018_04.pdf
[262] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Humatrope_somatropin_Art.46_PAR_005_2018_04.pdf
[263] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Priorix_Art.46_PAR_2018_04.pdf
[264] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214341.pdf
[265] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215354.pdf
[266] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Hydroquinidine_PSUR_SAR.pdf
[267] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Hydroxyzine/human_referral_prac_000043.jsp&mid=WC0b01ac05805c516f
[268] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500254741.pdf
[269] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ibuprofen_and_dexibuprofen_containing_medicines/human_referral_prac_000045.jsp&mid=WC0b01ac05805c516f
[270] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500240798.pdf
[271] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500246743.pdf
[272] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ibutilide_SAR_2014_02.pdf
[273] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/idarubicin.pdf
[274] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Imipenem_cilastatin_PSUR_SAR_2015_12.pdf
[275] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2018/08/WC500253111.pdf
[276] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Inactivated_Hepatitis_A_virus_antigen_Art45_PAR_12_2017.pdf
[277] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/influenza_vaccine__split_virion_inactivated__SAR_2015_10.pdf
[278] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Indium_SAR_2014_01.pdf
[279] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Indobufen_Summary_AR_2015_05.pdf
[280] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Infanrix_-_2018_07_-_45PaedAR_.pdf
[281] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214398.pdf
[282] https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-9-12-march-2020-prac_pl.pdf
[283] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-6-9-july-2020-prac_pl.pdf
[284] http://www.ema.europa.eu/docs/en_GB/document_library/PRAC_recommendation_on_signal/2017/05/WC500227846.pdf
[285] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2018/01/WC500240924.pdf
[286] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Interferon_alfa_2a_SAR_2014_12.pdf
[287] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500246675.pdf
[288] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/iobitridol_SAR_2015_10.pdf
[289] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214421.pdf
[290] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ipratropium.pdf
[291] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ipratropium_salbutamol.pdf
[292] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500239348.pdf
[293] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Irinotecan_SAR_2017_10.pdf
[294] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245046.pdf
[295] https://www.ema.europa.eu/documents/psusa-conclusions/iron-parenteral-preparations-cmdh-scientific-conclusions-grounds-variation-amendments-product/00010236/201801_pl.pdf
[296] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214424.pdf
[297] https://urpl.gov.pl/sites/default/files/zalaczniki/WC500234071.pdf
[298] https://www.ema.europa.eu/documents/psusa/isotretinoin-oral-formulations-cmdh-scientific-conclusions-grounds-variation-amendments-product/00010488/201805_pl.pdf
[299] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Isradipine_SAR_2016_03.pdf
[300] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ivermectin_SAR_2015_11.pdf
[301] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500241861.pdf
[302] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/02/WC500220684.pdf
[303] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Ketamine_Art_45_PAR_2017_10.pdf
[304] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ketoprofen__except_topical_use__SAR_2014_03.pdf
[305] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ketoprofen__topical_use_only__SAR_2015_10.pdf
[306] https://www.ema.europa.eu/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-29-31-october-2018_pl.pdf
[307] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Labetalol_PSUR_SAR_2015_12.pdf
[308] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Lamotrigine_SAR_2014_04.pdf
[309] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/09/WC500255159.pdf
[310] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Landiolol_SAR_12_2017.pdf
[311] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500242012.pdf
[312] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Latanoprost_timolol_Summary_AR_2015_05.pdf
[313] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/lenograstim_SAR_2015_10.pdf
[314] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/08/WC500233852.pdf
[315] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/07/WC500232076.pdf
[316] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/06/WC500250001.pdf
[317] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/10/WC500215146.pdf
[318] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237226.pdf
[319] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/levobupivacaine.pdf
[320] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Levocetirizine_PSUR_SAR_2017_05.pdf
[321] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500248145.pdf
[322] https://www.ema.europa.eu/documents/psusa/levonorgestrel-cmdh-scientific-conclusions-grounds-variation-amendments-product-information/00001856/201712_pl.pdf
[323] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/levosimendan_SAR_2014_07.pdf
[324] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Lidocaine_Hydrochloride_Art._46_PAR_01_2018_.pdf
[325] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/lomustine_SAR_2014_06.pdf
[326] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Loratadine_SAR_2014_12.pdf
[327] https://www.ema.europa.eu/documents/psusa/lorazepam-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00001909/201801_pl.pdf
[328] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214524.pdf
[329] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/04/WC500225202.pdf
[330] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Losartan_hydrochlorothiazide_SAR_2014_02.pdf
[331] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Lovastatin_SAR_2014_04.pdf
[332] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Lubiprostone_Summary_AR_2015_05.pdf
[333] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Lymecycline_Art_45_PAR_01_2018.pdf
[334] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/macrogol_4000_PSUR_SAR.pdf
[335] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Macrogol_4000_and_combinations_PSUR_SAR_2015_12.pdf
[336] https://urpl.gov.pl/sites/default/files/zalaczniki/WC500234327.pdf
[337] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Mefloquine_SAR_2016_01.pdf
[338] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500240837.pdf
[339] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/05/WC500226851.pdf
[340] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Mepivacaine_PSUR_SAR_2016_02.pdf
[341] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214534.pdf
[342] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Mesalazine_PSUR_SAR_2015_12.pdf
[343] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2017/09/WC500235456.pdf
[344] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/05/WC500248916.pdf
[345] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245168.pdf
[346] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245013.pdf
[347] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Methylphenidate_hydrochloride_SAR_2014_09.pdf
[348] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214544.pdf
[349] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Medicinal_products_containing_lactose_of_bovine_origin_for_IV/human_referral_prac_000063.jsp&mid=WC0b01ac05805c516f
[350] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214547.pdf
[351] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-30-august-2-september_pl.pdf
[352] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214549.pdf
[353] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245306.pdf
[354] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/milnacipran_SAR_2015_10.pdf
[355] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214561.pdf
[356] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214565.pdf
[357] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/mirtazapine.pdf
[358] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500247181.pdf
[359] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500223583.pdf
[360] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/misoprostol_gynaecological_indication_PSUR_SAR.pdf
[361] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245490.pdf
[362] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/09/WC500254804.pdf
[363] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Moclobemide_SAR_2014_04.pdf
[364] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/modafinil_PSUR_SAR.pdf
[365] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/mometasone_salicylic_acid_SAR_2014_07.pdf
[366] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500252934.pdf
[367] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500222940.pdf
[368] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/mycophenolic_acid_SAR_2014_06.pdf
[369] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/nabumetone.pdf
[370] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/N-acetyl-aspartyl-glutamic_acid_2018_09.pdf
[371] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500223103.pdf
[372] https://www.ema.europa.eu/documents/psusa/nadroparin-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00002104/201803_pl.pdf
[373] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/nafarelin_PSUR_SAR.pdf
[374] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Naloxone_2018_03.pdf
[375] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/06/WC500250085.pdf
[376] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/06/WC500208118.pdf
[377] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Nebivolol_SAR_2014_02.pdf
[378] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Nedocromil_PSUR_SAR_2015_12.pdf
[379] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500223345.pdf
[380] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500222861.pdf
[381] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/nicardipine_SAR_2014_07.pdf
[382] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214576.pdf
[383] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/nifuroxazide_PSUR_SAR.pdf
[384] https://www.ema.europa.eu/documents/psusa/nitrofurantoin-nifurtoinol-cmdh-scientific-conclusions-grounds-variation-amendments-product/00002174/201802_pl.pdf
[385] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500247125.pdf
[386] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Nilvadipine_SAR_2014_01.pdf
[387] https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-10-13-february-2020-prac-meeting_en.pdf
[388] https://www.ema.europa.eu/documents/psusa/nomegestrol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00002181/201801_pl.pdf
[389] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Nortriptyline_SAR_2014_03.pdf
[390] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237399.pdf
[391] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/octreotide_PSUR_SAR.pdf
[392] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ofloxacin_SAR_2014_10.pdf
[393] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214585.pdf
[394] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214587.pdf
[395] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/05/WC500206033.pdf
[396] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/02/WC500201457.pdf
[397] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500238410.pdf
[398] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214592.pdf
[399] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214594.pdf
[400] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/oxaliplatin_PSUR_SAR.pdf
[401] https://www.ema.europa.eu/documents/psusa/oxaliplatin-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00002229/201804_pl.pdf
[402] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Oxatomide_SAR_2014_10.pdf
[403] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/oxcarbazepine_SAR_2015_09.pdf
[404] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Oxybutinin_2015_01.pdf
[405] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Oxytetracycline_2018_09.pdf
[406] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ozenoxacin_PSUR_WS_-_SAR_2018_07.pdf
[407] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/04/WC500248171.pdf
[408] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500237535.pdf
[409] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500215208.pdf
[410] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Paclitaxel_SAR_2014_10.pdf
[411] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214596.pdf
[412] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214291.pdf
[413] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Paracetamol_Tramadol_SAR_2016_05.pdf
[414] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Paracetamol_for_infusion_PSUR_SAR_2015_12.pdf
[415] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Paricalcitol_SAR_2014_12.pdf
[416] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Rabeprazole_2018_03_Art.46.pdf
[417] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/paroxetine_SAR_2014_05.pdf
[418] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/09/WC500255200.pdf
[419] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Penciclovir_topical_use_only_SAR_2014_04.pdf
[420] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214330.pdf
[421] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/06/WC500250225.pdf
[422] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214371.pdf
[423] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/pimecrolimus_SAR_2015_10.pdf
[424] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Piretanide_PSUR_SAR_2016_02.pdf
[425] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214417.pdf
[426] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/pravastatin_SAR_2015_11.pdf
[427] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Pravastatin-aspirin_SAR_2016_09.pdf
[428] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Praziquantel_SAR_2016_01.pdf
[429] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-8-11-february-2021_pl.pdf
[430] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Priorix_2018_09.pdf
[431] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Priorix_Art.46_PAR_11_2017.pdf
[432] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Priorix_Art._46_PAR_2019_01.pdf
[433] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Procyanidolic_oligomers_SmAR_2018_04_.pdf
[434] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/12/WC500240715.pdf
[435] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Propofol_SAR_2015_06.pdf
[436] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/09/WC500255338.pdf
[437] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214426.pdf
[438] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500253810.pdf
[439] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Quetiapine_fumarate_PSUR_SAR_2015_12_rev.1.pdf
[440] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214450.pdf
[441] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Rabbit_anti-human_thymocyte_immunoglobulin_SAR_2014_03.pdf
[442] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/07/WC500232371.pdf
[443] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/12/WC500218339.pdf
[444] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ramipril_PSUR_SAR_2016_02.pdf
[445] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Ranitidine_SAR_2014_12.pdf
[446] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Interferon_gamma-1b_SAR_2014_04.pdf
[447] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Remifentanil_SmAR_July_2017.pdf
[448] http://www.ema.europa.eu/docs/pl_PL/document_library/Other/2016/07/WC500209641.pdf
[449] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214480.pdf
[450] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Risperidone_PSUR_SAR_2016_02.pdf
[451] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/rizatriptan_benzoate_SAR_2014_06.pdf
[452] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/05/WC500226615.pdf
[453] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/ropivacaine_SAR_2015_09.pdf
[454] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500254712.pdf
[455] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/10/WC500236919.pdf
[456] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/rupatadine.pdf
[457] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Rupatadine_as_fumarate_PSUR_SAR.pdf
[458] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Sabrilex_2019_08.pdf
[459] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/11/WC500238766.pdf
[460] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Sativex_2018_09.pdf
[461] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Seretide_Evohaler_Art.46_PAR_2018_10.pdf
[462] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Simvastatin_PSUR_SAR.pdf
[463] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500242167.pdf
[464] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Sodium_Iodide__123I__SAR_2014_03.pdf
[465] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/01/WC500240900.pdf
[466] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/solifenacin_PSUR_SAR.pdf
[467] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Solifenacin-tamsulosin_Summary_AR_2015_05.pdf
[468] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214556.pdf
[469] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Standardised_allergen_extract_from_house_dust_mites__Dermatophagoides_pteronyssinus_and_Dermatophagoides_farina_Acarizax__Amitend__Aitaro_November_2017.pdf
[470] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Strontium__89Sr__chloride_PSUR_SAR_2015_12.pdf
[471] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/sufentanil_citrate_SAR_2014_05.pdf
[472] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/sulbactam_PSUR_SAR.pdf
[473] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500223136.pdf
[474] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/sulproston_PSUR_SAR.pdf
[475] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/09/WC500254930.pdf
[476] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Technetium_albumin_nanocolloid_SAR_2014_01.pdf
[477] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Technetium__99mTc__exametazime_SAR_2014_03.pdf
[478] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Technetium_Tc-99m_bicisate_2014_11.pdf
[479] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214737.pdf
[480] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214740.pdf
[481] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Testosterone-containing_medicines/human_referral_prac_000037.jsp&mid=WC0b01ac05805c516f
[482] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/11/WC500215720.pdf
[483] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/11/WC500215589.pdf
[484] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/11/WC500215721.pdf
[485] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214745.pdf
[486] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214751.pdf
[487] http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/05/WC500206912.pdf
[488] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/01/WC500220338.pdf
[489] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tiagabine_hydrochloride_PSUR_SAR_2015_12.pdf
[490] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tianeptine_Summary_AR_2015_05.pdf
[491] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/tiapride_SAR_2015_11.pdf
[492] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tibolone_SAR_2014_10.pdf
[493] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tick-borne_encephalitis_vaccine_inactivated_SAR_2014_12.pdf
[494] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214717.pdf
[495] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Tinidazole_-_Art._45_PAR__2018_11.pdf
[496] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tioconazol_SAR_2014_12.pdf
[497] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/tirofiban_hydrochlorid_SAR_2014_07.pdf
[498] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Clavulanic_acid_and_ticarcillin_2018_09.pdf
[499] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tixocortol_Tixocortol_chlorhexidine_PSUR_SAR_2015_12.pdf
[500] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/08/WC500233886.pdf
[501] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214301.pdf
[502] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/TOBI_02_2018_Art.46_PAR.pdf
[503] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Tolterodine_SAR_2014_10.pdf
[504] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245268.pdf
[505] http://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2016/10/WC500214305.pdf
[506] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Trandolapril_verapamil_SAR_2014_04.pdf
[507] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/03/WC500223135.pdf
[508] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2018/08/WC500252906.pdf
[509] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Triamcinolone_acetonide_2018_09.pdf
[510] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2016/12/WC500218957.pdf
[511] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Trileptal_-_Art._46_PAR__2018_11.pdf
[512] http://www.ema.europa.eu/docs/pl_PL/document_library/Periodic_safety_update_single_assessment/2017/05/WC500226850.pdf
[513] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Tropicamide_Art_45_PAR_2019_01.pdf
[514] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Typhim_Vi_2018_09.pdf
[515] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Valaciclovir_SAR_2016_01.pdf
[516] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f
[517] https://www.ema.europa.eu/documents/psusa-conclusions/valproic-acid-sodium-valproate-valproate-pivoxil-valproate-semisodium-valpromide-cmdh-scientific/00003090/201801_pl.pdf
[518] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/valsartan_PSUR_SAR.pdf
[519] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Varicella_vaccine__live__SAR_2017_03.pdf
[520] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-part-1-vaxzevria-adopted-prac_pl.pdf
[521] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/vecuronium_bromide_PSUR_SAR.pdf
[522] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Venlafaxine_SAR_2017_11.pdf
[523] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/Zafirlukast_SAR_2014_04.pdf
[524] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_46_work-sharing/Azithromycin_2019_01__Art.46_PAR.pdf
[525] http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Pharmacovigilance_Legislation/PSUR/Summary_AR/zolmitriptan_SAR_2014_05.pdf
[526] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-e-5-8-july-2021-prac_pl.pdf
[527] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-part-1-adopted-prac-meeting-7_pl.pdf
[528] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-part-2-adopted-prac-meeting-7_pl.pdf
[529] https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-29-november-2-december_pl.pdf