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PRODUCT DETAIL

Thiotepa Fresenius Kabi 100 mg

Code 3351E
MA number 44/0086/23-S
Product Form: plc ifc 1x100 mg (liek.inj.skl.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01A ALKYLATING AGENTS
L01AC Ethylene imines
L01AC01 Thiotepa
Shelf life: 24
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 30.03.2023
Validity: 30.03.2028
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Thiotepa Fresenius Kabi_03 2023.pdf  
PIL: PIL_Thiotepa Fresenius Kabi_03 2023.pdf  
Safety feature Yes
Data update: 11.04.2023
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