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The marketing authorisation for Lenalidomide Krka d.d. has been withdrawn at the request of the marketing-authorisation holder.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
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Lenalidomide Krka d.d. : EPAR - Risk-management-plan summary
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Product information
Lenalidomide Krka d.d. : EPAR - Product information
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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
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Lenalidomide Krka d.d. : EPAR - Conditions imposed on member states for safe and effective use
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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
ImmunosuppressantsTherapeutic 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
Lenalidomide Krka d.d. : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (198.01 KB - PDF)
Lenalidomide Krka d.d. : EPAR - Public assessment report
English (EN) (2.38 MB - PDF)
CHMP summary of positive opinion for Lenalidomide Krka d.d.
English (EN) (211.26 KB - PDF)
News on Lenalidomide Krka d.d.
More information on Lenalidomide Krka d.d.
Public statement on Lenalidomide Krka d.d. : Withdrawal of the marketing authorisation in the European Union
English (EN) (106.79 KB - PDF)