MAR-PERINDOPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL

Dosage:

8MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 8MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0127178003; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-04-11

Summary of Product characteristics

_MAR-PERINDOPRIL (Perindopril Erbumine Tablets) Product Monograph_
_ _
_Page 1 of 64 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-PERINDOPRIL
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite 112
Ottawa, ON K2E 1A2
Canada
Date of Initial Authorization:
APR 11, 2018
Date of Revision:
MAY 17, 2023
Submission Control Number: 271178
_MAR-PERINDOPRIL (Perindopril Erbumine Tablets) Product Monograph_
_ _
_Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
...............................................................................................................
2
TABLE OF CONTENTS
..................................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics (< 18 years of age)
............................................................................................................
4
1.2
Geriatrics (>65 years of age)
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
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