Q-PRAVASTATIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
31-05-2013
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Aktivna sestavina:
PRAVASTATIN SODIUM
Dostopno od:
QD PHARMACEUTICALS ULC
Koda artikla:
C10AA03
INN (mednarodno ime):
PRAVASTATIN
Odmerek:
10MG
Farmacevtska oblika:
TABLET
Sestava:
PRAVASTATIN SODIUM 10MG
Pot uporabe:
ORAL
Enote v paketu:
30/100
Tip zastaranja:
Prescription
Terapevtsko območje:
HMG-COA REDUCTASE INHIBITORS
Povzetek izdelek:
Active ingredient group (AIG) number: 0122563001; AHFS:
Status dovoljenje:
CANCELLED PRE MARKET
Datum dovoljenje:
2015-08-21
Lastnosti izdelka
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_47_
PRODUCT MONOGRAPH
PR
Q-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 164225
Date of Revision: May 31, 2013
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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
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION ............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
32
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