Tepadina (thiotepa)
- Region
- 🇪🇺 EU
- Active substance
- thiotepa
- Status
- Authorised
- Therapeutic area
- Hematopoietic Stem Cell Transplantation
- CHMP opinion
- Thu 17 Dec 2009
- EU approval
- Mon 15 Mar 2010
- Application
- EMEA/H/C/001046
- ATC
- L01AC01
- Official record
- www.ema.europa.eu
Indication
TEPADINA 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
- 🇪🇺 Thiotepa Riemser Authorised · Esteve Pharmaceuticals GmbH
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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.