Product class: Authorized package
Medicinal product class: For human use
Package code: 1843860
Name of medicinal product: THIOTEPA RIEMSER
Active substances:
Thiotepa
Estonian, English, Latin
ATC code: L01AC01
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 15mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 02 April 2024
Marketing authorization holder: Esteve Pharmaceuticals GmbH 
Marketing authorization number: EU/1/21/1536 
Marketing authorization issued on: 26 March 2021 
Marketing authorization expires on: 29 March 2026 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 27 February 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription