Lenalidomide Krka d.d.
lenalidomide
Table of contents
Overview
The marketing authorisation for Lenalidomide Krka d.d. has been withdrawn at the request of the marketing-authorisation holder.
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Lenalidomide Krka d.d. : EPAR - Medicine overview (PDF/259.95 KB)
First published: 18/02/2021
Last updated: 10/07/2023
EMA/11795/2021 -
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Lenalidomide Krka d.d. : EPAR - Risk-management-plan summary (PDF/470.17 KB)
First published: 18/02/2021
Last updated: 10/07/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Lenalidomide Krka d.d.
|
| Agency product number |
EMEA/H/C/005729
|
| Active substance |
lenalidomide hydrochloride hydrate
|
| International non-proprietary name (INN) or common name |
lenalidomide
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L04AX04
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Krka, d.d., Novo mesto
|
| Revision |
2
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| Date of issue of marketing authorisation valid throughout the European Union |
11/02/2021
|
| Contact address |
Krka, d.d., Novo mesto |
Product information
13/12/2021 Lenalidomide Krka d.d. - EMEA/H/C/005729 - IB/0003
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).
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. 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).