- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 8 June 2023, the European Commission withdrew the marketing authorisation for Lenalidomide Krka d.d. (lenalidomide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, KRKA, d.d., Novo mesto, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Lenalidomide Krka d.d. was granted marketing authorisation in the EU on 11 February 2021 for the treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma. The marketing authorisation was initially valid for a 5-year period.
Lenalidomide Krka d.d. is a generic medicine of Revlimid. There are other generic medicinal products of Revlimid authorised and marketed in the EU.
The European Public Assessment Report (EPAR) for Lenalidomide Krka d.d. is updated to indicate that the marketing authorisation is no longer valid.
Product information
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).
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).