MYLAN-VERAPAMIL SR TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-06-2015
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Active ingredient:
VERAPAMIL HYDROCHLORIDE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
C08DA01
INN (International Name):
VERAPAMIL
Dosage:
180MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
VERAPAMIL HYDROCHLORIDE 180MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0113846004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-06-13
Summary of Product characteristics
_Mylan-Verapamil SR Product Monograph _
_Page 1 of 42 _
PRODUCT MONOGRAPH
PR
MYLAN-VERAPAMIL SR
verapamil hydrochloride sustained-release tablets
120 mg, 180 mg and 240 mg
Antihypertensive Agent
Mylan Pharmaceuticals ULC
Date of Preparation:
85 Advance Road
July 15, 2009
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
June 3, 2015
Submission Control No: 184288
_Mylan-Verapamil SR Product Monograph _
_Page 2 of 42 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
..........................................................................31
DETAILED PHARMACOLOGY
..................................................................
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