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