MINT-PRAVASTATIN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
08-03-2024
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Aktivní složka:
PRAVASTATIN SODIUM
Dostupné s:
MINT PHARMACEUTICALS INC
ATC kód:
C10AA03
INN (Mezinárodní Name):
PRAVASTATIN
Dávkování:
10MG
Léková forma:
TABLET
Složení:
PRAVASTATIN SODIUM 10MG
Podání:
ORAL
Jednotky v balení:
30/100
Druh předpisu:
Prescription
Terapeutické oblasti:
HMG-COA REDUCTASE INHIBITORS
Přehled produktů:
Active ingredient group (AIG) number: 0122563001; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2021-02-09
Charakteristika produktu
Page 1 of 39
PRODUCT MONOGRAPH
Pr
MINT-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Mint Pharmaceuticals Inc.,
6575 Davand Drive
Mississauga, ON
L5T 2M3
Date of Preparation:
MAR 08, 2024
Control# 283801
Page 2 of 39
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
................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
21
PART II: SCIENTIFIC INFORMATION
...................................................................................................
22
PHARMACEUTICAL INFORMATION
...............
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