Lenalidomide Krka d.d.



This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Lenalidomide Krka d.d. has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 10/07/2023

Authorisation details

Product details
Lenalidomide Krka d.d.
Agency product number
Active substance
lenalidomide hydrochloride hydrate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Lymphoma, Follicular
  • Myelodysplastic Syndromes
Anatomical therapeutic chemical (ATC) code

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
Krka, d.d., Novo mesto 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

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

Product information

13/12/2021 Lenalidomide Krka d.d. - EMEA/H/C/005729 - IB/0003

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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).

Assessment history

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