NOVO-VERAMIL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

VERAPAMIL HYDROCHLORIDE

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

C08DA01

INN (Nome Internazionale):

VERAPAMIL

Dosaggio:

80MG

Forma farmaceutica:

TABLET

Composizione:

VERAPAMIL HYDROCHLORIDE 80MG

Via di somministrazione:

ORAL

Confezione:

100/500/1000

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2018-05-15

Scheda tecnica

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