NIASPAN FCT TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

NICOTINIC ACID

Saatavilla:

SUNOVION PHARMACEUTICALS CANADA INC

ATC-koodi:

C10AD02

INN (Kansainvälinen yleisnimi):

NICOTINIC ACID

Annos:

500MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

NICOTINIC ACID 500MG

Antoreitti:

ORAL

Kpl paketissa:

3/90

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTILIPEMIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2019-07-22

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
NIASPAN FCT
®
Extended-Release Niacin
500 mg and 1000 mg Extended-Release Film Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
Sunovion Pharmaceuticals Canada Inc.
6790 Century Ave., Suite 100
Mississauga, Ontario
Canada
DATE OF REVISION:
October 18, 2017
SUBMISSION CONTROL NUMBER:
208538
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
...........................................................................................................
7
DRUG INTERACTIONS
..........................................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................................
12
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
15
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL INFORMATION
.................................................................................
18
CLINICAL
TRIALS.................................................................