Concept paper on the revision of the CVMP guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1 Corr.1)

Human medicines European public assessment report (EPAR): Grasustek, pegfilgrastim, Date of authorisation: 20/06/2019, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Paxneury, guanfacine, Date of authorisation: 26/02/2025, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Qinlock, ripretinib, Date of authorisation: 18/11/2021, Revision: 11, Status: Authorised

Plasma master file timetable: 60-day - Period 2026-2028

Plasma master file timetable: 30-day - Period 2026-2028

Electronic product information (ePI)

Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Date of authorisation: 06/03/2009, Revision: 23, Status: Authorised

ICH E14/S7B (R1) Q&As: The clinical evaluation of QT/ QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - Questions and Answers

Human medicines European public assessment report (EPAR): Procysbi, mercaptamine, Date of authorisation: 05/09/2013, Revision: 19, Status: Authorised