VICTRELIS CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

BOCEPREVIR

제공처:

MERCK CANADA INC

ATC 코드:

J05AP03

INN (International Name):

BOCEPREVIR

복용량:

200MG

약제 형태:

CAPSULE

구성:

BOCEPREVIR 200MG

관리 경로:

ORAL

패키지 단위:

14/168

처방전 유형:

Prescription

치료 영역:

HCV Antivirals

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-01-10

제품 특성 요약

_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
.......................