ZEPATIER TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ELBASVIR; GRAZOPREVIR

Available from:

MERCK CANADA INC

ATC code:

J05AP54

INN (International Name):

ELBASVIR AND GRAZOPREVIR

Dosage:

50MG; 100MG

Pharmaceutical form:

TABLET

Composition:

ELBASVIR 50MG; GRAZOPREVIR 100MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

HCV Replication Complex Inhibitors

Product summary:

Active ingredient group (AIG) number: 0257730001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-08-16

Summary of Product characteristics

_ _
_ZEPATIER_
_®_
_ (elbasvir/grazoprevir) Tablets _
_Page 1 of 65 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ZEPATIER
®
elbasvir/grazoprevir tablets
50 mg/100 mg
Antiviral Agent
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Preparation:
January 19, 2016
Date of Revision:
March 17, 2021
Submission Control No: 245140
_ _
_ZEPATIER_
_®_
_ (elbasvir/grazoprevir) Tablets _
_Page 2 of 65 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
..............................................................................................
10
DRUG INTERACTIONS
..............................................................................................
14
DOSAGE AND ADMINISTRATION
...........................................................................
26
OVERDOSAGE
............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 29
STORAGE AND STABILITY
......................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
....................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 33
PART II: SCIENTIFIC INFORMATION
............................................................................
34
PHARMACEUTICAL
INFORMATION....................................................