Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Folotyn
Active substance: Pralatrexate
Indication: FOLOTYN is indicated for the treatment of adult patients with peripheral T-cell lymphoma (nodal, extranodal and leukaemic/disseminated) who have progressed after at least one prior therapy.
Marketing Authorisation Holder: Allos Therapeutics Limited

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Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/06/2012 Centralised - Refusal of marketing authorisation EMEA/H/C/2096 (2012)4351 of 21/06/2012