APO-NEBIVOLOL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-09-2019
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Active ingredient:
NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
C07AB12
INN (International Name):
NEBIVOLOL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0153531002; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-12-22
Summary of Product characteristics
Page 1 of 34
PRODUCT MONOGRAPH
PR
APO-NEBIVOLOL
Nebivolol Tablets
2.5 mg, 5 mg and 20 mg Nebivolol
(as nebivolol hydrochloride)
Antihypertensive Agent
APOTEX INC.
Date of Preparation:
150 Signet Drive
September 23, 2019
Toronto, Ontario
M9L 1T9
Submission Control No: 223530
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
3
SUMMARY PRODUCT INFORMATION
.......................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................................................
3
CONTRAINDICATIONS
..................................................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................................................
4
ADVERSE REACTIONS
..................................................................................................................................
7
DRUG INTERACTIONS
.................................................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................................................
13
OVERDOSAGE
...............................................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................................
15
STORAGE AND
STABILITY.........................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
..
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