Lenalidomide Krka d.d. (lenalidomide)
- Region
- 🇪🇺 EU
- Active substance
- lenalidomide
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Withdrawn
- Therapeutic area
- Multiple Myeloma; Lymphoma, Follicular; Myelodysplastic Syndromes
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Thu 11 Feb 2021
- Designations
- Generic
- Application
- EMEA/H/C/005729
- ATC
- L04AX04
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Lenalidomide Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Lenalidomide Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Revlimid Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Lenalidomide Celgene Europe Application withdrawn · Celgene Europe Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.