Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1835029
Name of medicinal product: THIOTEPA FRESENIUS KABI
Active substances:
Estonian, English, Latin
ATC code: L01AC01
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Thiotepa Fresenius Kabi 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):  (last updated May 8, 2023)
Package information leaflet (PIL): EST  (last updated May 8, 2023)
Labelling:  (last updated May 8, 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Fresenius Kabi Polska Sp. z o.o. 
Marketing authorization number: 1108723 
Marketing authorization issued on: May 8, 2023 
Marketing authorization expires on: May 8, 2028 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 30, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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