NTP-PRAVASTATIN TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
30-07-2013
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
PRAVASTATIN SODIUM
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
C10AA03
INN (Alþjóðlegt nafn):
PRAVASTATIN
Skammtar:
10MG
Lyfjaform:
TABLET
Samsetning:
PRAVASTATIN SODIUM 10MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HMG-COA REDUCTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0122563001; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2017-06-13
Vara einkenni
PRODUCT MONOGRAPH
Pr
NTP-PRAVASTATIN
pravastatin sodium tablets
10, 20 and 40 mg
Lipid Metabolism Regulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 166140
Date of Preparation:
July 23, 2013
_ _
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
.............................................................................................
10
DRUG INTERACTIONS
.............................................................................................
14
DOSAGE AND ADMINISTRATION
.........................................................................
16
OVERDOSAGE
...........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 17
STORAGE AND STABILITY
.....................................................................................
19
PART II: SCIENTIFIC INFORMATION
................................................................... 21
PHARMACEUTICAL INFORMATION
.....................................................................
21
CLINICAL TRIALS
.....................................................................................................
22
DETAILED PHARMACOLOGY
................................................................................
28
TOXICOLOGY
............................................................................................................
29
REFERENCES
................................................
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