NOVO-ACEBUTOLOL (TYPE S) TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-07-2007
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Active ingredient:
ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE)
Available from:
NOVOPHARM LIMITED
ATC code:
C07AB04
INN (International Name):
ACEBUTOLOL
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE) 200MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0131282003; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2015-10-16
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
NOVO-ACEBUTOLOL (TYPE S)
(Acebutolol Hydrochloride)
100, 200 and 400 mg Tablets
Novopharm Standard
ANTIHYPERTENSIVE AND ANTI-ANGINAL AGENT
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 103290, 110614
Date of Preparation:
May 11, 2007
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE.................................................................................................................11
ACTION AND CLINICAL
PHARMACOLOGY.............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL
INFORMATION..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
.......................................................
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