Thiotepa Riemser (thiotepa)
- Region
- 🇪🇺 EU
- Active substance
- thiotepa
- Company
- Esteve Pharmaceuticals GmbH
- Status
- Authorised
- Therapeutic area
- Hematopoietic Stem Cell Transplantation; Neoplasms
- CHMP opinion
- Thu 28 Jan 2021
- EU approval
- Fri 26 Mar 2021
- Designations
- Generic
- Application
- EMEA/H/C/005434
- ATC
- L01AC01
- Official record
- www.ema.europa.eu
Indication
Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tepadina Authorised ·
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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.