NOVO-VERAMIL TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
29-05-2013
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Aktívna zložka:
VERAPAMIL HYDROCHLORIDE
Dostupné z:
TEVA CANADA LIMITED
ATC kód:
C08DA01
INN (Medzinárodný Name):
VERAPAMIL
Dávkovanie:
80MG
Forma lieku:
TABLET
Zloženie:
VERAPAMIL HYDROCHLORIDE 80MG
Spôsob podávania:
ORAL
Počet v balení:
100/500/1000
Typ predpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0113846002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-05-15
Súhrn charakteristických
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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