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.
Related articles EMA recommends four new generics EMA recommends approval for two new generics Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.
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.
EMA recommends approval for arsenic trioxide and fampridine generics
Comments (0)
Generics News Research General
- Generics applications under review by EMA – Jan...Generics/General | Posted 22/01/2021
- Perspectives of prescribing practices in public...Generics/Research | Posted 15/01/2021
- A European pharmaceutical strategy promoting ge...Generics/General | Posted 08/01/2021
- Familiarity with substitution of prescription g...Generics/Research | Posted 11/12/2020
Biosimilars News Research General
- Samsung biosimilars: denosumab clinical trials...Biosimilars/General | Posted 22/01/2021
- Biosimilars of filgrastimBiosimilars/General | Posted 20/03/2015
- Biosimilars applications under review by EMA –...Biosimilars/General | Posted 15/01/2021
- EMA recommends approval of adalimumab and insul...Biosimilars/News | Posted 22/01/2021