NIASPAN TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-10-2015
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Active ingredient:
NICOTINIC ACID
Available from:
SUNOVION PHARMACEUTICALS CANADA INC
ATC code:
C10AD02
INN (International Name):
NICOTINIC ACID
Dosage:
1000MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
NICOTINIC ACID 1000MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTILIPEMIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0108396010; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-06-30
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
NIASPAN
®
Extended-Release Niacin
500 mg and 1000 mg Extended-Release Tablets
Lipid Metabolism Regulator
Manufacturer:
DATE OF REVISION:
Sunovion Pharmaceuticals Canada Inc.
October 23, 2015
6790 Century Ave. Suite 100
Mississauga, Ontario
Canada
Submission #: 185768
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
......................................................................................
12
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
14
STORAGE AND STABILITY
.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 16
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
.................................................................................
17
CLINICAL
TRIALS...............................................................................................
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