TEVA-AMLODIPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMLODIPINE (AMLODIPINE BESYLATE)

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

C08CA01

INN (Nama Internasional):

AMLODIPINE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100/250

Jenis Resep:

Prescription

Area terapi:

DIHYDROPYRIDINES

Ringkasan produk:

Active ingredient group (AIG) number: 0131437001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2021-07-29

Karakteristik produk

_Page 1_
PRODUCT MONOGRAPH
Pr
TEVA-AMLODIPINE
Amlodipine Besylate Tablets
5 mg and 10 mg amlodipine (amlodipine besylate)
Antihypertensive-Antianginal Agent
Teva Standard
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No: 241922
Date of Revision:
September 9, 2020
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY
PRODUCT
INFORMATION
.................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..........................................................................................
4
ADVERSE
REACTIONS
............................................................................................................
7
DRUG
INTERACTIONS
.............................................................................................................
9
DOSAGE
AND
ADMINISTRATION
.......................................................................................
13
OVERDOSAGE
.........................................................................................................................
14
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
14
STORAGE
AND
STABILITY...................................................................................................
17
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION
..................................................................................
19
CLINICAL
TRIALS
...............................