TEVA-AMLODIPINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

AMLODIPINE (AMLODIPINE BESYLATE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

C08CA01

INN (International Nazwa):

AMLODIPINE

Dawkowanie:

10MG

Forma farmaceutyczna:

TABLET

Skład:

AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/250

Typ recepty:

Prescription

Dziedzina terapeutyczna:

DIHYDROPYRIDINES

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2021-07-29

Charakterystyka produktu

_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
...............................