Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych |

URPLWMiPB

URPLWMiPB

Communication of the President of the Office, of the 14th of September 2023, on the recommendation of the CHMP Committee (EMA) for the marketing authorization of the adapted Spikevax vaccine against Covid-19, targeting the Omicron subvariant XBB.1.5.

14/09/2023
Communication of the President of the Office, of the 30th of August 2023, on the EMA's recommendation for marketing authorization of Comirnaty's adapted vaccine against Omicron subvariant XBB.1.5 for adults and children 6 months and older.

30/08/2023
Communication of the President of the Office of 18.08.2023 regarding the conduct by the EMA’s PRAC Committee of a review of data on the potential risk of neurodevelopmental disorders (NDDs) in children of men taking valproate-containing medicines.

18/08/2023
Communication of the President of the Office of 19 July 2023 regarding the EMA's statement on a draft document on the use of artificial intelligence (AI) to support the development, and use of human and veterinary medicines.

19/07/2023
Communication of the President of the Office of 18 July 2023 on recommendations issued by the EC, HMA and EMA on measures to avoid shortages of key antibiotics for the treatment of respiratory infections during the upcoming winter season.

18/07/2023
Communication of the President of the Office of 12 July 2023 regarding the European Medicines Agency's PRAC Committee's review of data on the risk of suicidal thoughts during GLP-1 receptor agonist therapy.

12/07/2023
Communication of the President of the Office of 05.07.2023 on the approval by the EMA of the joint statement on the safety of COVID-19 vaccines by the International Coalition of Medicines Regulatory Authorities (ICMRA)

05/07/2023