NOVO-ATORVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Tersedia dari:

NOVOPHARM LIMITED

Kode ATC:

C10AA05

INN (Nama Internasional):

ATORVASTATIN

Dosis:

20MG

Bentuk farmasi:

TABLET

Komposisi:

ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2015-10-26

Karakteristik produk

_Page 1_
PRODUCT MONOGRAPH
Pr
NOVO-ATORVASTATIN
Atorvastatin Calcium Tablets
10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as
atorvastatin calcium
)
LIPID METABOLISM REGULATOR
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 145821
Date of revision:
May 6, 2011
_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.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND
ADMINISTRATION.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND
STABILITY.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS.........................................................................................................
26
DETAILED
PHARMACOLOGY............................................................