On 19 January 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma. The company that applied for the authorisation is Allos Therapeutics Limited.
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 April 2012.
Questions and answers on the refusal of the marketing authorisation for Folotyn (pralatrexate) (PDF/54.94 KB)Adopted
First published: 20/04/2012
Last updated: 11/07/2012
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Allos Therapeutics Ltd
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