| Code | 1310C | ||||||||||
| MA number | 13/0445/16-S | ||||||||||
| Product Form: | con inj 5x2 ml (amp.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Amomed Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 13 - ANTIARRYTHMICA | ||||||||||
| ATC: |
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| Shelf life: | 18 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 29.09.2016 |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 28.10.2021 |