| Code | 95220 | ||||||||||
| MA number | 20/0416/05-S | ||||||||||
| Product Form: | sol inj 5x4 ml/8 mg (amp.skl.hnedá) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 10.11.2005 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Onsetrogen 2 mg_ml_sol inj_12_2022.pdf
|
| PIL: |
PIL_Onsetrogen 2 mg_ml_sol inj_10_2023.pdf
|
| Safety feature | Yes |
| Data update: | 07.11.2019 |
