| Code | 8312C | ||||||||||
| MA number | 44/0206/18-S | ||||||||||
| Product Form: | sol inj 1x5 ml/5 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 |
