SANDOZ SIMVASTATIN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

SIMVASTATIN

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

C10AA01

INN (International Adı):

SIMVASTATIN

Doz:

80MG

Farmasötik formu:

TABLET

Kompozisyon:

SIMVASTATIN 80MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

HMG-COA REDUCTASE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0122415005; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2021-04-13

Ürün özellikleri

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