SANDOZ SIMVASTATIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SIMVASTATIN

Disponibbli minn:

SANDOZ CANADA INCORPORATED

Kodiċi ATC:

C10AA01

INN (Isem Internazzjonali):

SIMVASTATIN

Dożaġġ:

20MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

SIMVASTATIN 20MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HMG-COA REDUCTASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0122415003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2021-04-13

Karatteristiċi tal-prodott

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_Sandoz Simvastatin _
_Page 1 of 50_
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PRODUCT MONOGRAPH
PR
SANDOZ SIMVASTATIN
SIMVASTATIN TABLETS, USP
5 MG, 10 MG, 20 MG, 40 MG AND 80 MG
LIPID METABOLISM REGULATOR
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
January 4, 2018
Boucherville, Quebec
J4B 7K8
Submission Control No.: 211930
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_Sandoz Simvastatin _
_Page 2 of 50_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMACOLOGY
.............