EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA paediatric investigation plans in-person training course, European Medicines Agency, Amsterdam, the Netherlands, from 5 November 2026, 08:00 (CET) to 6 November 2026, 16:30 (CET)
Human medicines European public assessment report (EPAR): Cabometyx, cabozantinib, Date of authorisation: 09/09/2016, Revision: 21, Status: Authorised
Human medicines European public assessment report (EPAR): Nexviadyme, avalglucosidase alfa, Date of authorisation: 24/06/2022, Revision: 7, Status: Authorised
Draft reflection paper on the investigation of drug interactions of herbal medicinal products
Human medicines European public assessment report (EPAR): Koselugo, selumetinib, Date of authorisation: 17/06/2021, Revision: 10, Status: Authorised
Academia
Opinion/decision on a Paediatric investigation plan (PIP): Opdualag, nivolumab,relatlimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0169/2024
Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), pretomanid, Date of authorisation: 31/07/2020, Revision: 16, Status: Authorised
Human medicines European public assessment report (EPAR): Fymskina, ustekinumab, Date of authorisation: 25/09/2024, Revision: 7, Status: Authorised