PERINDOPRIL ERBUMINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERINDOPRIL ERBUMINE

Available from:

SANIS HEALTH INC

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL

Dosage:

8MG

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL ERBUMINE 8MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-10-12

Summary of Product characteristics

_PERINDOPRIL ERBUMINE (Perindopril Erbumine Tablets, USP) Product
Monograph _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PERINDOPRIL ERBUMINE
Perindopril Erbumine Tablets, USP
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 275916
Date of Initial Authorization:
OCT 12, 2018
Date of Revision:
JUN
21, 2023
_PERINDOPRIL ERBUMINE (Perindopril Erbumine Tablets, USP) Product
Monograph _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
7 WARNING AND PRECAUTIONS
06/2023
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
..............................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.........................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................................
5
4.1
Dosing Considerations
.......................................................................