13 June 2013
Pharmacovigilance Risk Assessment Committee (PRAC)
The information in this report was compiled on 7 June 2013.
5. Risk Management Plans
5.1. Medicines in the pre-authorisation phase
The PRAC provided advice to the CHMP on the proposed RMPs for a number of products (identified by active substance below) that are under evaluation for initial marketing authorisation. Information on the PRAC advice will be available in the European Public Assessment Reports (EPARs) to be published at the end of the evaluation procedure
5.1.4. Sipuleucel-T..................Page 33