Post-authorisation safety studies (PASS)
Post-authorisation safety studies (PASS)
Post-authorisation safety studies (PASS)
Type-IA variations: questions and answers
Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Date of authorisation: 17/02/2012, Revision: 25, Status: Authorised
Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections
The team of the European Case Reports Journal in Internal Medicine, EJCRIM is in process of preparing the Book of Abstracts from the 22nd European Congress of Internal Medicine (Istanbul, 6–9 March).
The abstract book will be published on the EJCRIM website in the coming weeks!
If you want to be notified when the book will be online, sign up to the EJCRIM free alert service here.
Human medicines European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen), COVID-19 vaccine (Ad26.COV2-S [recombinant]), Date of authorisation: 11/03/2021, Revision: 31, Status: Authorised
HMPC: overview of assessment work - priority list
Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Date of authorisation: 18/05/2020, Revision: 15, Status: Authorised
List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Human medicines European public assessment report (EPAR): Pravafenix, fenofibrate,pravastatin, Date of authorisation: 14/04/2011, Revision: 9, Status: Authorised