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EMA recommends approval of Lenalidomide Mylan Posted 13/11/2020

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 October 2020 that it recommends granting marketing authorization for the generic medicine Lenalidomide Mylan (lenalidomide).

Lenalidomide Mylan, developed by Mylan Ireland Ltd, is intended for the treatment of multiple myeloma and follicular lymphoma. It is a generic of Celgene’s Revlimid, which has been authorised in the European Union (EU) since 14 June 2007.

Lenalidomide Mylan will be available as hard capsules (2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg). The active substance of Lenalidomide Mylan is lenalidomide, an immunomodulating agent that works in several different ways including through cytokine modulation, induction of T-cell proliferation, anti-proliferation of multiple myeloma cells and inhibition of angiogenesis.

Lenalidomide Mylan is one of 10 medicines that were recommended for approval at CHMP’s October 2020 meeting. The CHMP positive opinion for Lenalidomide Mylan will be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for Member States of the EU.

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