Lenalidomide Krka d.d.

Withdrawn

This medicine's authorisation has been withdrawn

lenalidomide

Overview

On 8 June 2023, the European Commission withdrew the marketing authorisation for Lenalidomide Krka d.d. (lenalidomide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, KRKA, d.d., Novo mesto, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Lenalidomide Krka d.d. was granted marketing authorisation in the EU on 11 February 2021 for the treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma. The marketing authorisation was initially valid for a 5-year period. 

Lenalidomide Krka d.d. is a generic medicine of Revlimid. There are other generic medicinal products of Revlimid authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Lenalidomide Krka d.d. is updated to indicate that the marketing authorisation is no longer valid.

Lenalidomide Krka d.d. : EPAR - Medicine overview

Reference Number: EMA/11795/2021

Lenalidomide Krka d.d. : EPAR - Risk-management-plan summary

Product information

Lenalidomide Krka d.d. : EPAR - Product information

Lenalidomide Krka d.d. : EPAR - All authorised presentations

Lenalidomide Krka d.d. : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Lenalidomide Krka d.d.
• Active substance:
  lenalidomide hydrochloride hydrate
• International non-proprietary name (INN) or common name:
  lenalidomide
• Therapeutic area (MeSH):
  • Multiple Myeloma
  • Lymphoma, Follicular
  • Myelodysplastic Syndromes
• Anatomical therapeutic chemical (ATC) code:
  L04AX04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Multiple myeloma

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

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

Myelodysplastic syndromes

Lenalidomide Krka d.d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Follicular lymphoma

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

Authorisation details

• EMA product number:
  EMEA/H/C/005729
• 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.

• Marketing authorisation holder:
  Krka, d.d., Novo mesto

  Krka, d.d., Novo mesto; Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Opinion adopted:
  10/12/2020
• Marketing authorisation issued:
  11/02/2021
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Lenalidomide Krka d.d. : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Lenalidomide Krka d.d. : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/3809/2021

CHMP summary of positive opinion for Lenalidomide Krka d.d.

Adopted Reference Number: EMA/CHMP/651085/2020