Lenalidomide Accord (lenalidomide)
- Region
- 🇪🇺 EU
- Active substance
- lenalidomide
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 26 Jul 2018
- EU approval
- Thu 20 Sep 2018
- Designations
- Generic
- Application
- EMEA/H/C/004857
- ATC
- L04AX04
- Official record
- www.ema.europa.eu
Indication
Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord 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 Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphomaLenalidomide Accord 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
- 🇪🇺 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- 🇪🇺 Lenalidomide Krka d.d. Withdrawn · KRKA tovarna zdravil d.d. Novo mesto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- 🇪🇺 Lenalidomide Celgene Europe Application withdrawn · Celgene Europe Limited
Follow Lenalidomide Accord
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.