M-PRAVASTATIN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
23-08-2017
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Aktivní složka:
PRAVASTATIN SODIUM
Dostupné s:
MANTRA PHARMA INC
ATC kód:
C10AA03
INN (Mezinárodní Name):
PRAVASTATIN
Dávkování:
40MG
Léková forma:
TABLET
Složení:
PRAVASTATIN SODIUM 40MG
Podání:
ORAL
Jednotky v balení:
100
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:
2018-04-19
Charakteristika produktu
Page 1 of 44
PRODUCT MONOGRAPH
Pr
M-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Mantra Pharma Inc.
Date of Preparation:
4605-B boul. Lapinière, Suite 250
August 15, 2017
Brossard, Quebec
J4Z 3T5
Control# 207352
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
................................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
21
PART II: SCIENTIFIC INFORMATION
...................................................................................................
23
PHARMACEUTICAL INFORMATION
.....
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