Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: TEPADINA
Active substances:
Thiotepa
Estonian, English, Latin
ATC code: L01AC01
Dosage form: powder for concentrate for solution for infusion
Strength: 15mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Adienne S.r.l. 
Marketing authorization number: EU/1/10/622 
Marketing authorization issued on: March 15, 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1462193  TEPADINA  powder for concentrate for solution for infusion  15mg 1TK  Prescription      07.02.2023     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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