Lenalidomide Mylan

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lenalidomide

Authorised
This medicine is authorised for use in the European Union.

Overview

Lenalidomide Mylan is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.

In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Mylan is used:

  • in adults with previously untreated (newly diagnosed) multiple myeloma, who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor);
  • in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
  • in adults whose disease has been treated at least once. It is used in combination with dexamethasone.

In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Mylan is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.

Lenalidomide Mylan contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid.

This EPAR was last updated on 07/01/2021

Authorisation details

Product details
Name
Lenalidomide Mylan
Agency product number
EMEA/H/C/005306
Active substance
lenalidomide
International non-proprietary name (INN) or common name
lenalidomide
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L04AX
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
18/12/2020
Contact address

Unit 35/36
Grange Parade
Baldoye
Industrial Estate
Dublin 13
Ireland

Product information

18/12/2020 Lenalidomide Mylan - EMEA/H/C/005306 -

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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 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).

Assessment history

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