ADVICOR TABLET (IMMEDIATE RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

NICOTINIC ACID; LOVASTATIN

Disponible depuis:

SEPRACOR PHARMACEUTICALS INC

Code ATC:

C10BA01

DCI (Dénomination commune internationale):

LOVASTATIN AND NICOTINIC ACID

Dosage:

500MG; 20MG

forme pharmaceutique:

TABLET (IMMEDIATE RELEASE)

Composition:

NICOTINIC ACID 500MG; LOVASTATIN 20MG

Mode d'administration:

ORAL

Unités en paquet:

3/90

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HMG-COA REDUCTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0251302001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2012-08-02

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
ADVICOR
®
extended-release niacin and lovastatin tablets
500/20 mg, 750/20 mg, 1000/20 mg and 1000/40 mg Film-Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
DATE OF REVISION
:
Sepracor Pharmaceuticals, Inc.
OCTOBER 29, 2010
Mississauga, Ontario
Canada
CONTROL NO. 141231
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
.........................................................................................................
10
DRUG
INTERACTIONS..........................................................................................................
16
DOSAGE AND
ADMINISTRATION......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
19
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL
TRIALS...........................................................................................