AURO-ENTECAVIR TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

MAH:

AURO PHARMA INC

ATC_code:

J05AF10

INN:

ENTECAVIR

dosage:

0.5MG

pharmaceutical_form:

TABLET

composition:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 0.5MG

administration_route:

ORAL

units_in_package:

30/100/1000

prescription_type:

Prescription

therapeutic_area:

NUCLEOSIDES AND NUCLEOTIDES

leaflet_short:

Active ingredient group (AIG) number: 0151648001; AHFS:

authorization_status:

APPROVED

authorization_date:

2015-11-09

SPC

Page 1 of 43
PRODUCT MONOGRAPH
PR
AURO-ENTECAVIR
tablets
0.5 mg entecavir (as monohydrate)
Antiviral
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
DATE OF REVISION:
February 5, 2019
SUBMISSION CONTROL NO.
224160
Page 2 of 43
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
...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE…………………………………………………………………………12
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 12
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................................................
20
CLINICAL TRIALS
.........................................................................................................
21
DETAILED PHARMACOLOGY
....................................................................................
28
TOXICOLOGY
...............