NOVO-VERAMIL TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

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SPC SPC (SPC)
29-05-2013

active_ingredient:

VERAPAMIL HYDROCHLORIDE

MAH:

TEVA CANADA LIMITED

ATC_code:

C08DA01

INN:

VERAPAMIL

dosage:

80MG

pharmaceutical_form:

TABLET

composition:

VERAPAMIL HYDROCHLORIDE 80MG

administration_route:

ORAL

units_in_package:

100/500/1000

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0113846002; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-05-15

SPC

                                PRODUCT MONOGRAPH
PR
NOVO-VERAMIL
(verapamil hydrochloride)
80 mg, 120 mg tablets
Antiarrhythmic/Antianginal/Antihypertensive Agent
PR
NOVO-VERAMIL SR
(verapamil hydrochloride)
240 mg sustained release tablets
Antihypertensive Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
May 28, 2013
Toronto, Ontario
M1B 2K9
Submission Control No: 164741
2
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
...............................................................................................................
9
DRUG INTERACTIONS
.............................................................................................................
12
DOSAGE AND ADMINISTRATION
.........................................................................................
18
OVERDOSAGE
...........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
21
STORAGE AND STABILITY
.....................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL INFORMATION
...................................................................................
                                
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SPC SPC ֆրանսերեն 28-05-2013