Land: Canada
Taal: Engels
Bron: Health Canada
OBETICHOLIC ACID
ADVANZ PHARMA CANADA INC.
A05AA04
OBETICHOLIC ACID
10MG
TABLET
OBETICHOLIC ACID 10MG
ORAL
15G/50G
Prescription
MISCELLANEOUS GI DRUGS
Active ingredient group (AIG) number: 0158950002; AHFS:
APPROVED
2022-11-16
_OCALIVA (Obeticholic Acid) Tablets _ _Page 1 of 34_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr OCALIVA ® Obeticholic acid tablets Tablets 5 mg and 10 mg, Oral Farnesoid X Receptor (FXR) Agonist OCALIVA, indicated for: • the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or • as monotherapy in adults unable to tolerate UDCA, has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for OCALIVA please refer to Health Canada’s Notice of Compliance with conditions - drug products web site: https://www.canada.ca/en/health- canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html ADVANZ PHARMA CANADA Inc. 4263 Sherwoodtowne Blvd., Suite 300 Mississauga, Ontario L4Z 1Y5 Submission Control Number: 268803 Date of Initial Authorization: NOV 16, 2022 _ _ _OCALIVA_ _ (Obeticholic Acid)_ _ Tablets _ _Page 2 of 34_ WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)? _An NOC/c is a form of market approval granted to a product on the basis of _ _promising evidence of clinical effectiveness following review of the submission by _ _Health Canada. _ _Products authorized under Health Canada’s NOC/c policy are intended for the _ _treatment, prevention or diagnosis of a serious, life-threatening or severely _ _debilitating illness. They have demonstrated promising benefit, are of high quality _ _and possess an acceptable safety profile based on a benefit/risk assessment. In _ _addition, they either respond to a serious unmet medical need in Canada or have _ _demonstrated a significant improvement in the benefit/risk profile over existing _ _therapies. Health Canada has provided access to this product on the condition that _ _sponsors carry out additional clinical trials to verify the anticipated benefit within an _ _agreed upon time frame Lees het volledige document