Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)

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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 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 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 follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. Novo mesto. Lenalidomide Krka d.d. Novo mesto 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 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 17/12/2021

Authorisation details

Product details
Name
Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
Agency product number
EMEA/H/C/005734
Active substance
lenalidomide hydrochloride monohydrate
International non-proprietary name (INN) or common name
lenalidomide
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Lymphoma, Follicular
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 
Revision
3
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

13/12/2021 Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) - EMEA/H/C/005734 - IB/0004

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

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.

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).

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.

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

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