AG-PERINDOPRIL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PERINDOPRIL ERBUMINE

Tersedia dari:

ANGITA PHARMA INC.

Kode ATC:

C09AA04

INN (Nama Internasional):

PERINDOPRIL

Dosis:

2MG

Bentuk farmasi:

TABLET

Komposisi:

PERINDOPRIL ERBUMINE 2MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-10-16

Karakteristik produk

_AG-Perindopril (Perindopril Erbumine Tablets) Product Monograph_
_ _
_Page 1 of 64 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-PERINDOPRIL
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 276805
Date of Initial Authorization:
OCT 16, 2018
Date of Revision:
JUL 25, 2023
_AG-Perindopril (Perindopril Erbumine Tablets) Product Monograph_
_ _
_Page 2 of 64 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
7 WARNINGS AND PRECAUTIONS
07/2023
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)
.............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
......................................................................................................................
5