| Code | 1607C | ||||||||||
| MA number | 20/0477/16-S | ||||||||||
| Product Form: | sol inj 10x5 ml/250 µg (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: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 09.11.2016 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Palonosetron Fresenius Kabi 250 mikrogramov injekčný roztok_august2021.pdf
|
| SPC: |
SPC_Palonosetron Fresenius Kabi 250 mikrogramov injekčný roztok_august2021.pdf
|
| Safety feature | Yes |
| Data update: | 11.08.2021 |
