TEVA-AMLODIPINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
09-09-2020
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Aktiv bestanddel:
AMLODIPINE (AMLODIPINE BESYLATE)
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
C08CA01
INN (International Name):
AMLODIPINE
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
AMLODIPINE (AMLODIPINE BESYLATE) 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/250
Recept type:
Prescription
Terapeutisk område:
DIHYDROPYRIDINES
Produkt oversigt:
Active ingredient group (AIG) number: 0131437001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2021-07-29
Produktets egenskaber
_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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