TEVA-AMLODIPINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-09-2020
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Active ingredient:
AMLODIPINE (AMLODIPINE BESYLATE)
Available from:
TEVA CANADA LIMITED
ATC code:
C08CA01
INN (International Name):
AMLODIPINE
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
AMLODIPINE (AMLODIPINE BESYLATE) 10MG
Administration route:
ORAL
Units in package:
100/250
Prescription type:
Prescription
Therapeutic area:
DIHYDROPYRIDINES
Product summary:
Active ingredient group (AIG) number: 0131437001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-07-29
Summary of Product characteristics
_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
...............................
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