Code | 4504E | ||||||||||
MA number | 44/0457/15-S | ||||||||||
Product Form: | sol inf 10x150 ml/1500 mg (vak.inf.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | infusion bag | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 26.11.2015 |
Pediatric posology: | Yes |
SPC: | SPC_Gemcitabín SUN 10 mg_ml infúzny roztok_03.2024.pdf |
PIL: | PIL_Gemcitabín SUN 10 mg_ml infúzny roztok_03.2024.pdf |
Safety feature | Yes |
Data update: | 03.10.2023 |