ADVICOR TABLET (IMMEDIATE RELEASE)

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

NICOTINIC ACID; LOVASTATIN

Available from:

SEPRACOR PHARMACEUTICALS INC

ATC code:

C10BA01

INN (International Name):

LOVASTATIN AND NICOTINIC ACID

Dosage:

1000MG; 40MG

Pharmaceutical form:

TABLET (IMMEDIATE RELEASE)

Composition:

NICOTINIC ACID 1000MG; LOVASTATIN 40MG

Administration route:

ORAL

Units in package:

90

Prescription type:

Prescription

Therapeutic area:

HMG-COA REDUCTASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0251302004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-07-26

Summary of Product characteristics

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