EU Regulatory System Incident Management Plan for Medicines for Human Use

Business process description for pharmacovigilance

Lenalidomide Mylan

What we publish on medicines and when

EMEA-001260-PIP01-11-M03

EMEA-002996-PIP01-21

Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Oncology, PIP number: P/0271/2021

Human medicines European public assessment report (EPAR): Phesgo, pertuzumab,trastuzumab, Date of authorisation: 21/12/2020, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Votrient, pazopanib, Date of authorisation: 14/06/2010, Revision: 32, Status: Authorised

Advanced therapy classification