PRAVASTATIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
20-02-2012
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
PRAVASTATIN SODIUM
Inapatikana kutoka:
COBALT PHARMACEUTICALS COMPANY
ATC kanuni:
C10AA03
INN (Jina la Kimataifa):
PRAVASTATIN
Kipimo:
40MG
Dawa fomu:
TABLET
Tungo:
PRAVASTATIN SODIUM 40MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30/100/500
Dawa ya aina:
Prescription
Eneo la matibabu:
HMG-COA REDUCTASE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0122563003; AHFS:
Idhini hali ya:
CANCELLED PRE MARKET
Idhini ya tarehe:
2017-09-01
Tabia za bidhaa
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_Page 1 of 44_
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg Tablets
USP
Lipid Metabolism Regulator
Manufactured by:
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Revision:
February 20, 2012
Submission Control No: 153301
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_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.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.........................................................................
23
CLINICAL
TRIALS.........................................................................................................
24
DETAILED
PHARMACOLOGY.................................................
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