| Code | 4150B | ||||||||||
| MA number | 44/0186/15-S | ||||||||||
| Product Form: | con inf 1x26,3 ml/1000 mg (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 22.05.2015 |
| Pediatric posology: | Yes |
| SPC: |
SPC_Gemcitabine Kabi 38 mg_ml koncentrát na infúzny roztok _06.2024.pdf
|
| PIL: |
PIL_Gemcitabine Kabi 38 mg_ml koncentrát na infúzny roztok_06.2024.pdf
|
| Safety feature | Yes |
| Data update: | 20.06.2024 |
