Impulsor

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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 Medicament.

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
Impulsor
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

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