| Code | 3350E | ||||||||||
| MA number | 44/0085/23-S | ||||||||||
| Product Form: | plc ifc 1x15 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 15 | ||||||||||
| 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 |
| PIL: |
PIL_Thiotepa Fresenius Kabi 15 mg_07.2024.pdf
|
| SPC: |
SPC_Thiotepa Fresenius Kabi 15 mg_10.2025.pdf
|
| Safety feature | Yes |
| Data update: | 11.04.2023 |
