...because the Pharmacovigilance Risk Assessment Committee (PRAC) has provided a Risk management plan (RMP) to the CHMP it seems that Lorcaserin will get approval with imposed conditions!
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
Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/91065/2013 Page 16/69
the PRAC advice will be available in the European Public Assessment Reports (EPARs) to be published at the end of the evaluation procedure.
5.1.8. Lorcaserin Hydrochloride
• Evaluation of the RMP in the context of an initial Marketing Authorisation Application procedure
jmho - do your own DD before deciding!