Lenalidomide Mylan (lenalidomide)
- Region
- 🇪🇺 EU
- Active substance
- lenalidomide
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 15 Oct 2020
- EU approval
- Fri 18 Dec 2020
- Designations
- Generic
- Application
- EMEA/H/C/005306
- ATC
- L04AX07
- Official record
- www.ema.europa.eu
Indication
Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Mylan 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 Mylan 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
Lenalidomide Mylan (lenalidomide): DHPC sent to healthcare professionals
Quality defect; Multiple Myeloma · source
Same substance in other markets
- 🇪🇺 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- 🇪🇺 Lenalidomide Krka d.d. Withdrawn · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 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- 🇪🇺 Lenalidomide Celgene Europe Application withdrawn · Celgene Europe Limited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.