| Code | 3864D | ||||||||||
| MA number | EU/1/15/1001/003 | ||||||||||
| Product Form: | plc ifc 1x235 mg/0,25 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Helsinn Birex Pharmaceuticals Ltd., Ireland | ||||||||||
| Therapeutic Class: | 20 - ANTIEMETICA, ANTIVERTIGINOSA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 16.03.2020 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 01.07.2021 |