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.
Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament / Impulsor (PDF/40.85 KB)
First published: 20/11/2009
Last updated: 20/11/2009
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Pierre Fabre Medicament
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|Date of refusal of marketing authorisation||