APO-ENTECAVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-01-2023
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Active ingredient:
ENTECAVIR
Available from:
APOTEX INC
ATC code:
J05AF10
INN (International Name):
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
Product summary:
Active ingredient group (AIG) number: 0151648001; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-11-23
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
APO-ENTECAVIR
Entecavir Tablets
Tablets 0.5 mg
USP
Antiviral
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Preparation:
November 23, 2012
Date of Revision:
January 11, 2023
Submission Control Number: 271047
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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
PHARMAC
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