JAMP ENTECAVIR TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

MAH:

JAMP PHARMA CORPORATION

ATC_code:

J05AF10

INN:

ENTECAVIR

dosage:

0.5MG

pharmaceutical_form:

TABLET

composition:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 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:

2017-08-17

SPC

1
PRODUCT MONOGRAPH
PR
JAMP ENTECAVIR
Entecavir
Tablets, House Standard
0.5 mg entecavir (as entecavir monohydrate)
Antiviral
Date of Preparation:
February 20, 2019
JAMP Pharma Corporation
1310 Nobel Street,
Boucherville, Québec,
J4B 5H3
Control No. 215406
2
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
..............................................................................................................
8
DRUG
INTERACTIONS..........................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
13
OVERDOSAGE
...........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
14
STORAGE AND STABILITY
....................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 24
PART II: SCIENTIFIC INFORMATION
..................................................................................
25
PHARMACEUTICAL INFORMATION
....................................................................................
25
CLINICAL TRIALS
.........................................................................................