MYLAN-ATORVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C10AA05

INN (Nama Internasional):

ATORVASTATIN

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Rute administrasi :

ORAL

Unit dalam paket:

90/500

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0133055001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2016-05-20

Karakteristik produk

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_Page 1_
I
PRODUCT MONOGRAPH
PR
MYLAN-ATORVASTATIN
ATORVASTATIN CALCIUM TABLETS
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
DATE OF REVISION : MAY 3, 2016
SUBMISSION CONTROL NO.: 194039
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_Page 2 _
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
............................................................................................................
11
DRUG INTERACTIONS
............................................................................................................
14
DOSAGE AND ADMINISTRATION
........................................................................................
22
OVERDOSAGE
..........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
24
STORAGE AND STABILITY
....................................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 27
PART II: SCIENTIFIC INFORMATION
..................................................................................
28
PHARMACEUTICAL INFORMATION
.......................................