PRAVASTATIN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
20-02-2012
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Aktivní složka:
PRAVASTATIN SODIUM
Dostupné s:
COBALT PHARMACEUTICALS COMPANY
ATC kód:
C10AA03
INN (Mezinárodní Name):
PRAVASTATIN
Dávkování:
40MG
Léková forma:
TABLET
Složení:
PRAVASTATIN SODIUM 40MG
Podání:
ORAL
Jednotky v balení:
30/100/500
Druh předpisu:
Prescription
Terapeutické oblasti:
HMG-COA REDUCTASE INHIBITORS
Přehled produktů:
Active ingredient group (AIG) number: 0122563003; AHFS:
Stav Autorizace:
CANCELLED PRE MARKET
Datum autorizace:
2017-09-01
Charakteristika produktu
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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Manufactured by:
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Revision:
February 20, 2012
Submission Control No: 153301
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_Page 2 of 44_
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
.................................................................................................
15
DOSAGE AND
ADMINISTRATION.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND
STABILITY.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.........................................................................
23
CLINICAL
TRIALS.........................................................................................................
24
DETAILED
PHARMACOLOGY.................................................
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