PMS-ENTECAVIR TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ENTECAVIR

MAH:

PHARMASCIENCE INC

ATC_code:

J05AF10

INN:

ENTECAVIR

dosage:

0.5MG

pharmaceutical_form:

TABLET

composition:

ENTECAVIR 0.5MG

administration_route:

ORAL

units_in_package:

30

prescription_type:

Prescription

therapeutic_area:

NUCLEOSIDES AND NUCLEOTIDES

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2014-08-26

SPC

PRODUCT MONOGRAPH
Pr
PMS-ENTECAVIR
Entecavir Tablets, USP
0.5 mg and 1 mg
ANTIVIRAL
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
March 22, 2022
Submission
Control No: 256242
_pms-ENTECAVIR Product Monograph _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................3
WARNINGS AND PRECAUTIONS
.............................................................................3
ADVERSE
REACTIONS..............................................................................................7
DRUG INTERACTIONS
............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
12
OVERDOSAGE
.........................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
13
STORAGE AND STABILITY
....................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 20
PART II: SCIENTIFIC INFORMATION
..........................................................................
22
PHARMACEUTICAL INFORMATION
.....................................................................
22
CLINICAL TRIALS
...................................................................................................
23
DETAILED
PHARMACOLOGY................................................................................
32
TOXICOLOGY
..................................