Kizfizo (temozolomide)
- Region
- 🇪🇺 EU
- Active substance
- temozolomide
- Company
- ORPHELIA Pharma
- Status
- Refused
- Therapeutic area
- Neuroblastoma
- CHMP opinion
- Thu 27 Feb 2025
- Application
- EMEA/H/C/006169
- ATC
- L01AX03
- Official record
- www.ema.europa.eu
Indication
Treatment of neuroblastoma.
Regulatory milestones
Mon 21 Dec 2026🇪🇺 Expected EC decisionestimate
Kizfizo (temozolomide): expected EC decision
Estimated as CHMP opinion (2026-10-15) + 67 days, the standard Commission decision period. Not an official date. · ORPHELIA Pharma · source
Thu 15 Oct 2026🇪🇺 CHMP positive opinion
Kizfizo (temozolomide): CHMP positive opinion
ORPHELIA Pharma; Orphan · source
Same substance in other markets
- 🇪🇺 Kizfizo Opinion · ORPHELIA Pharma
- 🇪🇺 Temodal Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 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- 🇪🇺 Temozolomide Sandoz Withdrawn · Sandoz GmbH
- 🇪🇺 Temozolomide Hexal Withdrawn · Hexal AG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
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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.