MYLAN-SIMVASTATIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
31-07-2019
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:
SIMVASTATIN
Inapatikana kutoka:
MYLAN PHARMACEUTICALS ULC
ATC kanuni:
C10AA01
INN (Jina la Kimataifa):
SIMVASTATIN
Kipimo:
80MG
Dawa fomu:
TABLET
Tungo:
SIMVASTATIN 80MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
HMG-COA REDUCTASE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0122415005; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2019-09-17
Tabia za bidhaa
PRODUCT MONOGRAPH
PR
MYLAN-SIMVASTATIN
(Simvastatin Tablets)
5 mg, 10 mg, 20 mg, 40 mg and 80 mg
USP
Lipid Metabolism Regulator
Mylan Pharmaceuticals ULC
DATE OF REVISION: July 31, 2019
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Submission Number: 230095
_ _
_Product Monograph –Mylan_-_Simvastatin _
_Page 2 of 50 _
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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
27
DETAILED PHARMACOLOGY
...................................
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