| Code | 3155F | ||||||||
| MA number | 76/0120/26-S | ||||||||
| Product Form: | sol inj 20x20 ml (amp.PP) | ||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||
| Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||
| Container: | ampoule PP | ||||||||
| Route of admin.: | Parenteral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 01.04.2026 |
| Validity: | 01.04.2031 |
| Pediatric warnings: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | No |
| Data update: | 01.04.2026 |