| Code | 9122E | ||||||||||
| MA number | EU/1/24/1898/001 | ||||||||||
| Product Form: | cps dur 30x10 mg (fľ.HDPE) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Gilead Sciences Ireland UC , Ireland | ||||||||||
| Therapeutic Class: | 43 - CHOLERETICA, CHOLEKINETICA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 20.02.2025 |
| Validity: | 20.02.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 29.04.2025 |
