NIASPAN FCT TABLET (EXTENDED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

NICOTINIC ACID

Commercializzato da:

SUNOVION PHARMACEUTICALS CANADA INC

Codice ATC:

C10AD02

INN (Nome Internazionale):

NICOTINIC ACID

Dosaggio:

1000MG

Forma farmaceutica:

TABLET (EXTENDED-RELEASE)

Composizione:

NICOTINIC ACID 1000MG

Via di somministrazione:

ORAL

Confezione:

90

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTILIPEMIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2019-07-22

Scheda tecnica

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