MYLAN-PRAVASTATIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
12-05-2017
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Aktiv bestanddel:
PRAVASTATIN SODIUM
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
C10AA03
INN (International Name):
PRAVASTATIN
Dosering:
40MG
Lægemiddelform:
TABLET
Sammensætning:
PRAVASTATIN SODIUM 40MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
HMG-COA REDUCTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0122563003; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2017-08-02
Produktets egenskaber
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_49_
PRODUCT MONOGRAPH
PR
MYLAN-PRAVASTATIN
pravastatin sodium tablets
10 mg, 20 mg and 40 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 205285
Date of Revision: May 12, 2017
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_49_
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
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION ............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
................................................................................
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