Lenalidomide Krka d.d.

Withdrawn

This medicine's authorisation has been withdrawn

lenalidomide

Overview

The marketing authorisation for Lenalidomide Krka d.d. has been withdrawn at the request of the marketing-authorisation holder.

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

Latest procedure affecting product information: IB/0003

13/12/2021

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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

AdoptedReference Number: EMA/CHMP/3809/2021

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

AdoptedReference Number: EMA/CHMP/651085/2020