Temozolomide Sun (temozolomide)
- Region
- 🇪🇺 EU
- Active substance
- temozolomide
- Company
- Sun Pharmaceutical Industries Europe B.V.
- Status
- Authorised
- Therapeutic area
- Glioma
- EU approval
- Wed 13 Jul 2011
- Designations
- Generic
- Application
- EMEA/H/C/002198
- ATC
- L01AX03
- Official record
- www.ema.europa.eu
Indication
Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) 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
- 🇪🇺 Temodal Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Kizfizo Refused · ORPHELIA Pharma
- 🇪🇺 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- 🇪🇺 Temozolomide Sandoz Withdrawn · Sandoz GmbH
- 🇪🇺 Temozolomide Hexal Withdrawn · Hexal AG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
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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.