| Code | 9288D | ||||||||||
| MA number | 20/0306/21-S | ||||||||||
| Product Form: | sol ijf 5x2 ml/4 mg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intramuscular or intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.01.2022 |
| Validity: | 04.01.2027 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Ondansetron Kalceks 2 mg_ml injekčný_infúzny roztok_04_2022.pdf
|
| SPC: |
SPC_Ondansetron Kalceks 2 mg_ml injekčný_infúzny roztok_04_2022.pdf
|
| SPC: |
SPC_Ondansetron Kalceks 2 mg_ml injekčný_infúzny roztok_02_2023.pdf
|
| Safety feature | Yes |
| Data update: | 16.02.2023 |
