NOVO-VERAMIL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

VERAPAMIL HYDROCHLORIDE

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

C08DA01

DCI (Dénomination commune internationale):

VERAPAMIL

Dosage:

80MG

forme pharmaceutique:

TABLET

Composition:

VERAPAMIL HYDROCHLORIDE 80MG

Mode d'administration:

ORAL

Unités en paquet:

100/500/1000

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-05-15

Résumé des caractéristiques du produit

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
...................................................................................