Lenalidomide Krka d.d. Novo mesto

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lenalidomide

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

Overview

Lenalidomide Krka d.d. Novo mesto is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma.

In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka

d.d. Novo mesto is used:

  • in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced with the patient’s own stem cells to form new bone marrow);
  • in adults with previously untreated 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 myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide Krka d.d. Novo mesto is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic change (called deletion 5q) when other treatments are not adequate.

In mantle cell lymphoma and follicular lymphoma, blood cancers that affect a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. Novo mesto is used in adults whose disease has come back after treatment or does not improve with treatment. In follicular lymphoma it is used in combination with rituximab.

Lenalidomide Krka d.d. Novo mesto contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Krka d.d. Novo mesto contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document below.

This EPAR was last updated on 18/02/2021

Authorisation details

Product details
Name
Lenalidomide Krka d.d. Novo mesto
Agency product number
EMEA/H/C/005348
Active substance
lenalidomide hydrochloride monohydrate
International non-proprietary name (INN) or common name
lenalidomide
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
Anatomical therapeutic chemical (ATC) code
L04AX04
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
Krka, d.d., Novo mesto 
Date of issue of marketing authorisation valid throughout the European Union
11/02/2021
Contact address

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

Product information

11/02/2021 Lenalidomide Krka d.d. Novo mesto - EMEA/H/C/005348 -

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Multiple myeloma

Lenalidomide Krka d.d. Novo mesto 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. Novo mesto 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. Novo mesto 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. Novo mesto 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.

Mantle cell lymphoma

Lenalidomide Krka d.d. Novo mesto as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).

Follicular lymphoma

Lenalidomide Krka d.d. Novo mesto 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

Changes since initial authorisation of medicine

  • List item

    Lenalidomide Krka d.d. Novo mesto : EPAR - Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states (PDF/40.23 KB)


    First published: 18/02/2021

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