| Code | 1844F | ||||||||||
| MA number | 20/0380/25-S | ||||||||||
| Product Form: | sol inj 10x2 ml/4 mg (amp.PP-blister) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Intramuscular or intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 17.11.2025 |
| Validity: | 17.11.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Ondansetron Noridem 2 mg_ml injekčný roztok_11_2025.pdf
|
| SPC: |
SPC_Ondansetron Noridem 2 mg_ml injekčný roztok_11_2025.pdf
|
| Safety feature | Yes |
| Data update: | 18.11.2025 |
