| Code | 7786E | ||||||||||
| MA number | EU/1/24/1854/001 | ||||||||||
| Product Form: | cps dur 30x200 µg (fľ.HDPE) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Ipsen Pharma, France | ||||||||||
| Therapeutic Class: | 43 - CHOLERETICA, CHOLEKINETICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 19.09.2024 |
| Validity: | 19.09.2029 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 17.10.2024 |
