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