NIASPAN FCT TABLET (EXTENDED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

Compra'l ara

Descargar Fitxa tècnica (SPC)
18-10-2017

ingredients actius:

NICOTINIC ACID

Disponible des:

SUNOVION PHARMACEUTICALS CANADA INC

Codi ATC:

C10AD02

Designació comuna internacional (DCI):

NICOTINIC ACID

Dosis:

1000MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

NICOTINIC ACID 1000MG

Vía de administración:

ORAL

Unidades en paquete:

90

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTILIPEMIC AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2019-07-22

Fitxa tècnica

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