OCALIVA TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OBETICHOLIC ACID

Disponible desde:

ADVANZ PHARMA CANADA INC.

Código ATC:

A05AA04

Designación común internacional (DCI):

OBETICHOLIC ACID

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

OBETICHOLIC ACID 10MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS GI DRUGS

Resumen del producto:

Active ingredient group (AIG) number: 0158950002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-11-16

Ficha técnica

_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