| Code | 77585 | ||||||||
| MA number | 80/0348/09-S | ||||||||
| Product Form: | con inf 4x10 ml/250 mg (skl.amp.) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||
| MAH, country: | Recordati Rare Diseases, France | ||||||||
| Therapeutic Class: | 80 - HEPATICA | ||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||
| Container: | glass ampoule | ||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 25.06.2009 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 25.04.2024 |