VICTRELIS CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BOCEPREVIR

Disponible des:

MERCK CANADA INC

Codi ATC:

J05AP03

Designació comuna internacional (DCI):

BOCEPREVIR

Dosis:

200MG

formulario farmacéutico:

CAPSULE

Composición:

BOCEPREVIR 200MG

Vía de administración:

ORAL

Unidades en paquete:

14/168

tipo de receta:

Prescription

Área terapéutica:

HCV Antivirals

Resumen del producto:

Active ingredient group (AIG) number: 0152945001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2017-01-10

Fitxa tècnica

_VICTRELIS_
®
_ (boceprevir) _
_Page 1 of 64 _
PRODUCT MONOGRAPH
VICTRELIS
®
boceprevir
200 mg capsule
Hepatitis C Virus (HCV) Protease Inhibitor (PI)
MERCK CANADA INC.
Date of Revision:
16750, route Transcanadienne
May 27, 2015
Kirkland, QC Canada H9H 4M7
http://www.merck.ca
SUBMISSION CONTROL NO: 181892
_VICTRELIS_
®
_ (boceprevir) _
_Page 2 of 64 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNING AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
.......................