MYLAN-PRAVASTATIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

PRAVASTATIN SODIUM

Beszerezhető a:

MYLAN PHARMACEUTICALS ULC

ATC-kód:

C10AA03

INN (nemzetközi neve):

PRAVASTATIN

Adagolás:

20MG

Gyógyszerészeti forma:

TABLET

Összetétel:

PRAVASTATIN SODIUM 20MG

Az alkalmazás módja:

ORAL

db csomag:

30/100/500

Recept típusa:

Prescription

Terápiás terület:

HMG-COA REDUCTASE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0122563002; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2017-10-17

Termékjellemzők

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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
_Page 2 of _
_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
................................................................................