| Code | 2647F | ||||||||
| MA number | EU/1/25/1928/002 | ||||||||
| Product Form: | gru por 112 (4x28)x1 g (vre.Al/PE/papier) | ||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||
| Type of procedure: | EU Orphan | ||||||||
| MAH, country: | IntraBio Ireland Limited, Ireland | ||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||
| Container: | sachet paper/PE/Al | ||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 19.01.2026 |
| Validity: | 19.01.2031 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 04.02.2026 |
