Folotyn

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pralatrexate

Refused
This medicine was refused authorisation for use in the European Union.

Overview

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.

This EPAR was last updated on 11/07/2012

Application details

Product details
Name
Folotyn
Active substance
Pralatrexate
International non-proprietary name (INN) or common name
pralatrexate
Therapeutic area (MeSH)
Lymphoma, T-Cell
Anatomical therapeutic chemical (ATC) code
L01BA05
OrphanOrphan

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.

Application details
Marketing-authorisation applicant
Allos Therapeutics Ltd
Date of opinion
19/04/2012
Date of refusal of marketing authorisation
21/06/2012

Assessment history

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