EZETIMIBE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
20-01-2017
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Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
EZETIMIBE
Inapatikana kutoka:
SIVEM PHARMACEUTICALS ULC
ATC kanuni:
C10AX09
INN (Jina la Kimataifa):
EZETIMIBE
Kipimo:
10MG
Dawa fomu:
TABLET
Tungo:
EZETIMIBE 10MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30/100
Dawa ya aina:
Prescription
Eneo la matibabu:
CHOLESTEROL ABSORPTION INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0149164001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2014-09-15
Tabia za bidhaa
PRODUCT MONOGRAPH
PR
EZETIMIBE
EZETIMIBE TABLETS
10 MG
MANUFACTURER’S STANDARD
Cholesterol Absorption Inhibitor
Sivem Pharmaceuticals ULC
Date of Revision:
4705 Dobrin Street
January 17, 2017
St. Laurent, Quebec
H4R 2P7
www.sivem.ca
SUBMISSION CONTROL NO.: 200952
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
7
DRUG INTERACTIONS
............................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
14
STORAGE AND STABILITY
....................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 15
PART II: SCIENTIFIC INFORMATION
...................................................................................17
PHARMACEUTICAL INFORMATION
....................................................................................
17
CLINICAL TRIALS
.................................................................................
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