EZETIMIBE TABLET
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
20-01-2017
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
EZETIMIBE
Disponibbli minn:
SIVEM PHARMACEUTICALS ULC
Kodiċi ATC:
C10AX09
INN (Isem Internazzjonali):
EZETIMIBE
Dożaġġ:
10MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
EZETIMIBE 10MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
30/100
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
CHOLESTEROL ABSORPTION INHIBITORS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0149164001; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
2014-09-15
Karatteristiċi tal-prodott
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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