Product information
From Health Canada
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
DIN:
02463121
Product Monograph/Veterinary Labelling:
Date:
2018-10-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
INTERCEPT PHARMACEUTICALS INC.
200
9520 Towne Centre Dr
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
| 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 |