CATENA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IDEBENONE

Available from:

SANTHERA PHARMACEUTICALS (SWITZERLAND) LIMITED

ATC code:

N06BX13

INN (International Name):

IDEBENONE

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

IDEBENONE 150MG

Administration route:

ORAL

Units in package:

90

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

Active ingredient group (AIG) number: 0152473001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2013-04-30

Summary of Product characteristics

_ _
_Page 1 of 30_
PRODUCT MONOGRAPH
PR
CATENA
®
idebenone
150 mg oral tablet
ATP Production Modulator
_CATENA_
®
_, INDICATED FOR THE TREATMENT OF FRIEDREICH’S ATAXIA, _
_HAS BEEN ISSUED MARKET AUTHORIZATION WITH CONDITIONS, PENDING THE _
_RESULTS OF STUDIES TO VERIFY ITS CLINICAL BENEFIT. PATIENTS SHOULD BE
_
_ADVISED OF THE NATURE OF THE MARKET AUTHORIZATION GRANTED. _
Santhera Pharmaceuticals (Switzerland) Ltd
Hammerstrasse 49
CH-4410 Liestal
Switzerland
Canadian importer/distributor:
GMD Distributing Inc
1215B North Service Road
Oakville, ON L6M 2W2
Submission Control No: 139308
Date of Revision:
August 22, 2011
_ _
_Page 2 of 30_
PRODUCT MONOGRAPH GENERAL INFORMATION INSERT
THIS PRODUCT HAS BEEN APPROVED UNDER THE NOTICE OF COMPLIANCE
WITH CONDITIONS (NOC/C) POLICY FOR ONE OR ALL OF ITS INDICATED USES.
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.
WHAT WILL BE DIFFERENT ABOUT THIS PRODUCT MONOGRAPH?
The following Product Monograph will contain boxed text at the
beginning of each major section
clearly stating the nature of the market authorization. Sections for
which NOC/c status holds
particular significance will be identified in the left margin by the
symbol