| Code | 1431E | ||||||||||
| MA number | 20/0186/22-S | ||||||||||
| Product Form: | sol inf 20x50 ml/8 mg (fľ.LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi Deutschland GmbH, Germany | ||||||||||
| Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 01.07.2022 |
| Validity: | 01.07.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Ondansetron Kabi 0,08 mg_ml; 0,16 mg_ml_07 2022.pdf
|
| SPC: |
SPC_Ondansetron Kabi 0,08 mg_ml; 0,16 mg_ml_04_2024.pdf
|
| Safety feature | Yes |
| Data update: | 11.04.2024 |
