Drug · DIN 02463148
OCALIVA
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since December 7, 2023; first marketed May 26, 2017.
- Drug Identification Number (DIN)
- 02463148
- Company (DIN owner)
- Advanz Pharma Canada Inc.Mississauga, Ontario, Canada
- Schedule
- Prescription
- Dosage form
- Tablet
- Route
- Oral
- Therapeutic class (ATC)
- Obeticholic acid A05AA04
- Class
- Human
- Record last updated
- March 22, 2025
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| OBETICHOLIC ACID | 10 MG |
Notices of Compliance
Health Canada approvals that name this DIN.
- November 16, 2022: NOC 29483New Drug Submission (NDS) · Administrative: Manufacturer Name Change
- July 18, 2022: NOC 28610New Drug Submission (NDS) · Administrative: Change in Product Ownership
- October 11, 2018: NOC 21448Supplement to a New Drug Submission (SNDS) · To revise the labelling
- May 24, 2017: NOC 19342New Drug Submission (NDS)
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “ocaliva”. A notice may cover another product or only some lots: read it to see what it covers.
- OCALIVA (obeticholic acid) – New Contraindication for the Treatment of Primary Biliary Cholangitis (PBC)December 5, 2022 · Drugs · New safety information
Other DINs named OCALIVA
- DIN 02463121 · Marketed