| Code | 1293F | ||||||||||
| MA number | EU/1/25/1962/003 | ||||||||||
| Product Form: | tbl flm 28x100 mg (blis.PVC/PCTFE/Al) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Madrigal Pharmaceuticals EU Limited, Ireland | ||||||||||
| Therapeutic Class: | 80 - HEPATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PCTFE/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: | 18.08.2025 |
| Validity: | 18.08.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 01.10.2025 |
