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The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2017-05-26

Original market date: See footnote 1

2017-05-26

Product name:

OCALIVA

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02463121

Product Monograph/Veterinary Labelling:

Date: 2018-10-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

INTERCEPT PHARMACEUTICALS INC
4760 Eastgate Mall
San Diego
California
United States  92121

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:92.00   MISCELLANEOUS GI DRUGS

Anatomical Therapeutic Chemical (ATC): See footnote 4

A05AA04  OBETICHOLIC ACID

Active ingredient group (AIG) number:See footnote 5

0158950001

List of active ingredient(s)
Active ingredient(s) Strength
OBETICHOLIC ACID 5 MG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Additional Risk Minimization Measures
Healthcare Professional Education
Patient Education

Application information

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