PRAVASTATIN TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
10-09-2013
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Aktívna zložka:
PRAVASTATIN SODIUM
Dostupné z:
MELIAPHARM INC
ATC kód:
C10AA03
INN (Medzinárodný Name):
PRAVASTATIN
Dávkovanie:
20MG
Forma lieku:
TABLET
Zloženie:
PRAVASTATIN SODIUM 20MG
Spôsob podávania:
ORAL
Počet v balení:
100/500
Typ predpisu:
Prescription
Terapeutické oblasti:
HMG-COA REDUCTASE INHIBITORS
Prehľad produktov:
Active ingredient group (AIG) number: 0122563002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2014-06-25
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
PRAVASTATIN
Pravastatin Sodium Tablets, House Standard
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
September 10, 2013
Submission Control No: 167055
_ _
_PRAVASTATIN Product Monograph _
_Page 2 of 41_
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
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
..........................................................................................................
22
DETAILED PHARMACOLOGY
...........................
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