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Ocaliva
Licence EU/1/16/1139/001 · Unknown
- Licence holder
- Advanz Pharma Limited (all products →)
- Active substance
- Obeticholic acid
- Dosage form
- Film-coated tablet
- Route of administration
- Oral use
- ATC codes
- A05AA, A05AA04
- Prescription status
- Product subject to prescription which may be renewed (B)
- Supply
- Supply through pharmacies only
- Legal basis
- Full application (Article 8(3) of Directive No 2001/83/EC)
Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.