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
|