Lenalidomide Mylan

lenalidomide

Table of contents

Opinion

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lenalidomide Mylan, intended for the treatment of multiple myeloma and follicular lymphoma. The applicant for this medicinal product is Mylan Ireland Limited.

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 (ATC code: L04AX04) that works in a number of different ways including through cytokine modulation, induction of T-cell proliferation, anti-proliferation of multiple myeloma cells and inhibition of angiogenesis.

Lenalidomide Mylan is a generic of Revlimid, which has been authorised in the EU since 14 June 2007. Studies have demonstrated the satisfactory quality of Lenalidomide Mylan and its bioequivalence to the reference product Revlimid. 

The full indication is:

Multiple myeloma

Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Follicular lymphoma

Lenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Lenalidomide Mylan should be prescribed by physicians experienced in the use of cancer therapies.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Lenalidomide Mylan
Agency product number
EMEA/H/C/005306
International non-proprietary name (INN) or common name
  • lenalidomide
Active substance
  • lenalidomide
Therapeutic area
Multiple Myeloma
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
15/10/2020
Company name
Mylan Ireland Limited
Status
Positive
Application type
Initial authorisation

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