REPLAGAL SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AGALSIDASE ALFA

Tilgængelig fra:

TAKEDA CANADA INC

ATC-kode:

A16AB03

INN (International Name):

AGALSIDASE ALFA

Dosering:

1MG

Lægemiddelform:

SOLUTION

Sammensætning:

AGALSIDASE ALFA 1MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ENZYMES

Produkt oversigt:

Active ingredient group (AIG) number: 0149941001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2004-02-06

Produktets egenskaber

_REPLAGAL_
_®_
_ Product Monograph _
_Page 1 of 25 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REPLAGAL
®
agalsidase alfa for injection
1 mg/mL Concentrate for solution for intravenous infusion
Enzyme Replacement Therapy
REPLAGAL, indicated for:
- the long-term enzyme replacement therapy in patients with a
confirmed diagnosis of Fabry
Disease (α-galactosidase A deficiency)
has been issued marketing authorization with conditions, pending the
results of a trial to verify
its clinical benefit. Patients should be advised of the nature of the
authorization. For further
information for REPLAGAL 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
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Authorization:
FEB 10, 2017
Date of Revision:
October 20, 2021
Submission Control No: 245887
REPLAGAL
®
and the REPLAGAL Logo
®
are registered trademarks of Shire Human Genetic
Therapies, Inc.
TAKEDA™ and the TAKEDA Logo
®
are trademarks of Takeda Pharmaceutical Company
Limited, used under license.
_ _
_REPLAGAL_
_®_
_ Product Monograph _
_Page 2 of 25_
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 t