Lorcaserin will be approved in Europe! | ARNA Message Board Posts

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Msg  51266 of 220263  at  2/28/2013 6:29:37 AM  by

Franca_ole

The following message was updated on 2/28/2013 8:44:13 AM.

Lorcaserin will be approved in Europe!

  ...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!
 


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Msg # Subject Author Recs Date Posted
51269 Re: Lorcaserin will be approved in Europe! BigE 15 2/28/2013 7:24:01 AM


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