Milnacipran Pierre Fabre Medicament

RSS

milnacipran

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults. The company that applied for authorisation is Pierre Fabre Médicament.

The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.

This EPAR was last updated on 26/04/2010

Application details

Product details
Name
Milnacipran Pierre Fabre Medicament
Active substance
milnacipran
International non-proprietary name (INN) or common name
milnacipran
Therapeutic area (MeSH)
Fibromyalgia
Application details
Marketing-authorisation applicant
Pierre Fabre Medicament
Date of opinion
19/11/2009
Date of refusal of marketing authorisation
08/04/2010

Assessment history

How useful was this page?

Add your rating
Average
1 rating