NIASPAN TABLET (EXTENDED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

NICOTINIC ACID

MAH:

SUNOVION PHARMACEUTICALS CANADA INC

ATC_code:

C10AD02

INN:

NICOTINIC ACID

dosage:

500MG

pharmaceutical_form:

TABLET (EXTENDED-RELEASE)

composition:

NICOTINIC ACID 500MG

administration_route:

ORAL

units_in_package:

3/30

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTILIPEMIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0108396003; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2017-03-31

SPC

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...............................................................................................