| Code | 2617E | ||||||||||
| MA number | EU/1/22/1704/001 | ||||||||||
| Product Form: | sol por 1x30 ml/285 mg (fľ.PET) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| Therapeutic Class: | 43 - CHOLERETICA, CHOLEKINETICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Container: | bottle polyethylene terephtalate (PET) | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 09.12.2022 |
| Validity: | 09.12.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 14.08.2023 |
