Code | 2366C | ||||||||||
MA number | EU/1/16/1139/001 | ||||||||||
Product Form: | tbl flm 30x5 mg (fľ.HDPE) | ||||||||||
MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | ADVANZ PHARMA Limited, 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 8(3) application - new active substance |
MA issued: | 12.12.2016 |
Validity: | 15.12.2024 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC_Ocaliva_31.7.2024.pdf |
Safety feature | Yes |
Data update: | 24.11.2023 |