Code | 43663 | ||||||||||
MA number | 20/0255/07-S | ||||||||||
Product Form: | sol inj 5x4 ml/8 mg (amp.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | B.Braun Melsungen AG, Germany | ||||||||||
Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.07.2007 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Ondansetron B. Braun 2 mg_ml injekčný roztok_06_2022.pdf |
SPC: | SPC_Ondansetron B. Braun 2 mg_ml injekčný roztok_06_2022.pdf |
Safety feature | Yes |
Data update: | 26.02.2019 |