MYLAN-EZETIMIBE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
08-01-2015
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ingredients actius:
EZETIMIBE
Disponible des:
MYLAN PHARMACEUTICALS ULC
Codi ATC:
C10AX09
Designació comuna internacional (DCI):
EZETIMIBE
Dosis:
10MG
formulario farmacéutico:
TABLET
Composición:
EZETIMIBE 10MG
Vía de administración:
ORAL
Unidades en paquete:
30/100/500
tipo de receta:
Prescription
Área terapéutica:
CHOLESTEROL ABSORPTION INHIBITORS
Resumen del producto:
Active ingredient group (AIG) number: 0149164001; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2017-05-08
Fitxa tècnica
Page 1 of 30
PRODUCT MONOGRAPH
PR MYLAN-EZETIMIBE
Ezetimibe Tablets
10 mg
Cholesterol Absorption Inhibitor
Professed
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M9Z 2S6
Date of Revision: January 08, 2015
Submission Control No: 180299
Page 2 of 30
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION............................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
7
DRUG INTERACTIONS
...............................................................................................
11
DOSAGE AND ADMINISTRATION
...........................................................................
12
OVEROSAGE
.................................................................................................................
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
.......................................................................................................
18
TOXICOLOGY
...............................................................................................................
22
REFERENCES
........................
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