ATORVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Tersedia dari:

APOTEX INC

Kode ATC:

C10AA05

INN (Nama Internasional):

ATORVASTATIN

Dosis:

20MG

Bentuk farmasi:

TABLET

Komposisi:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG

Rute administrasi :

ORAL

Unit dalam paket:

250ML

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0133055002; AHFS:

Status otorisasi:

MARKETED

Tanggal Otorisasi:

2013-01-07

Karakteristik produk

Page 1 of 46
PRODUCT MONOGRAPH
Pr
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 5, 2012
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 159558
Page 2 of 46
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
......................................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................................
16
OVERDOSAGE
...................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
18
STORAGE AND STABILITY
.............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 21
PART II: SCIENTIFIC INFORMATION