Code | 8204D | ||||||||||
MA number | EU/1/21/1566/002 | ||||||||||
Product Form: | cps dur 30x400 µg (fľ.HDPE) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
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 8(3) application - new active substance |
MA issued: | 16.07.2021 |
Validity: | 16.07.2026 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 23.02.2024 |