RIVA-PERINDOPRIL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PERINDOPRIL ERBUMINE

Disponibil de la:

LABORATOIRE RIVA INC.

Codul ATC:

C09AA04

INN (nume internaţional):

PERINDOPRIL

Dozare:

2MG

Forma farmaceutică:

TABLET

Compoziție:

PERINDOPRIL ERBUMINE 2MG

Calea de administrare:

ORAL

Unități în pachet:

30/100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0127178001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-03-07

Caracteristicilor produsului

_RIVA-PERINDOPRIL (Perindopril Erbumine Tablets) _
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_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-PERINDOPRIL
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
LABORATOIRE RIVA INC.
660 Boul.
Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 276450
Date of Initial Authorization:
MAR 7, 2018
Date of Revision:
JUL 13, 2023
_RIVA-PERINDOPRIL (Perindopril Erbumine Tablets) _
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_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
7 WARNING AND PRECAUTIONS
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)
.....................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
.................................