SANDOZ SIMVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SIMVASTATIN

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

C10AA01

INN (Nama Internasional):

SIMVASTATIN

Dosis:

40MG

Bentuk farmasi:

TABLET

Komposisi:

SIMVASTATIN 40MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0122415002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2021-04-13

Karakteristik produk

_ _
_Sandoz Simvastatin _
_Page 1 of 50_
_ _
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
_ _
_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
.............