ATENOLOL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-11-2005
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Active ingredient:
ATENOLOL
Available from:
IVAX PHARMACEUTICALS INCORPORATED
ATC code:
C07AB03
INN (International Name):
ATENOLOL
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
ATENOLOL 50MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0113847002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2018-07-24
Summary of Product characteristics
_1_
PRODUCT MONOGRAPH
_Pr _
ATENOLOL TABLETS
Atenolol Tablets
50 mg and 100 mg
USP
Beta Adrenergic-receptor Blocking Agent
IVAX Pharmaceuticals, Inc.
140 Legrand Avenue
Northvale, New Jersey 07647
Control #: 099059
Canadian Distributor:
IVAX Pharmaceuticals Canada Inc.
1 Place Ville-Marie
Suite 3900
Montreal, Quebec
H3B 4M7
Date of Revision:
November 02, 2005
_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 . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 9
DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 12
DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 13
OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 14
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 16
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 17
SPECIAL HANDLING INSTRUCTIONS . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . 17
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 18
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 19
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 19
CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . .
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