Temodal (temozolomide)
- Region
- 🇪🇺 EU
- Active substance
- temozolomide
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Glioma
- CHMP opinion
- Thu 22 Oct 1998
- EU approval
- Tue 26 Jan 1999
- Application
- EMEA/H/C/000229
- ATC
- L01AX03
- Official record
- www.ema.europa.eu
Indication
Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Kizfizo Opinion · ORPHELIA Pharma
- 🇪🇺 Kizfizo Refused · ORPHELIA Pharma
- 🇪🇺 Temozolomide Sun Authorised · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Temozolomide Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Temozolomide Teva Authorised · Teva B.V.
- 🇪🇺 Temozolomide Sandoz Withdrawn · Sandoz GmbH
- 🇪🇺 Temozolomide Hexal Withdrawn · Hexal AG
- 🇪🇺 Temomedac Authorised · medac Gesellschaft für klinische Spezialpräparate mbH
Follow Temodal
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.