NIASPAN TABLET (EXTENDED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NICOTINIC ACID

Tersedia dari:

SUNOVION PHARMACEUTICALS CANADA INC

Kode ATC:

C10AD02

INN (Nama Internasional):

NICOTINIC ACID

Dosis:

1000MG

Bentuk farmasi:

TABLET (EXTENDED-RELEASE)

Komposisi:

NICOTINIC ACID 1000MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTILIPEMIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108396010; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-06-30

Karakteristik produk

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