Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
QRD Appendix V - Adverse-drug-reaction reporting details
Member states contact points for translations review
How to prepare and review a summary of product characteristics
Human medicines European public assessment report (EPAR): Qinlock, ripretinib, Gastrointestinal Stromal Tumors, Date of authorisation: 18/11/2021, Revision: 5, Status: Authorised
Human medicines European public assessment report (EPAR): Bavencio, avelumab, Neuroendocrine Tumors, Date of authorisation: 18/09/2017, Revision: 16, Status: Authorised
Opinion/decision on a Paediatric investigation plan (PIP): Gold (Au), decision type: , therapeutic area: , PIP number: P/0301/2022
Opinion/decision on a Paediatric investigation plan (PIP): Doxecitine,Doxribtimine, decision type: , therapeutic area: , PIP number: P/0287/2022
Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid,rosuvastatin calcium, decision type: , therapeutic area: , PIP number: P/0281/2022
Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0272/2022