MYLAN-PRAVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PRAVASTATIN SODIUM

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C10AA03

INN (Nama Internasional):

PRAVASTATIN

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

PRAVASTATIN SODIUM 10MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0122563001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-08-02

Karakteristik produk

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PRODUCT MONOGRAPH
PR
MYLAN-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 205285
Date of Revision: May 12, 2017
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_49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
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
................................................................................