Product class: Authorized package
Medicinal product class: For human use
Package code: 1462193
Name of medicinal product: TEPADINA
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: 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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 07 February 2023
Marketing authorization holder: Adienne S.r.l. 
Marketing authorization number: EU/1/10/622 
Marketing authorization issued on: 15 March 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 21 December 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription