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Published on 26 April 2012

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CHMP refuses Folotyn after re-application

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The Committee for Medicine Products for Human Use (CHMP) has refused, on re-examination of Allos Therapeutics Limited’s application, to recommend marketing authorisation for Folotyn (pralatrexate) for treatment of peripheral T-cell lymphoma. 

 

This follows its adoption of a negative opinion on 19 January 2012, when it recommended refusal of marketing authorisation for Folotyn for peripheral T-cell lymphoma.

 

Folotyn contains the active substance pralatrexate, and it was intended to be available as a solution for infusion. 

Folotyn was designated an ‘orphan medicine’, for use in rare diseases, 13 April 2007.

European Medicines Agency



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