Code | 8313C | ||||||||||
MA number | 44/0206/18-S | ||||||||||
Product Form: | sol inj 1x10 ml/10 mg (liek.PP - povolenie uvádzať na trh končí dňa 30.11.2025) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | container PP | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 22.06.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_ZAVEDOS 1 mg_ml injekčný roztok_polypropylénová injekčná liekovka_04.2022.pdf |
PIL: | PIL_ZAVEDOS 1 mg_ml injekčný roztok_polypropylénová injekčná liekovka_04.2022.pdf |
SPC: | SPC_ZAVEDOS 1 mg_ml injekčný roztok_sklenená liekovka_12.2023.pdf |
PIL: | PIL_ZAVEDOS 1 mg_ml injekčný roztok_sklenená liekovka_12.2023.pdf |
Safety feature | Yes |
Data update: | 14.12.2023 |