SANDOZ LOVASTATIN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LOVASTATIN

Tilgjengelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

C10AA02

INN (International Name):

LOVASTATIN

Dosering :

20MG

Legemiddelform:

TABLET

Sammensetning:

LOVASTATIN 20MG

Administreringsrute:

ORAL

Enheter i pakken:

100/500

Resept typen:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0120669002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2019-08-01

Preparatomtale

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_Sandoz Lovastatin _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR SANDOZ LOVASTATIN
Lovastatin Tablets USP
20 mg and 40 mg
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision: March 20, 2014
Submission Control Number: 172518
_ _
_Sandoz Lovastatin _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOGY
............................................