ZOVIRAX 800 TABLET

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

ACYCLOVIR

Available from:

GLAXOSMITHKLINE INC

ATC code:

J05AB01

INN (International Name):

ACYCLOVIR

Dosage:

800MG

Pharmaceutical form:

TABLET

Composition:

ACYCLOVIR 800MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Prescription

Therapeutic area:

NUCLEOSIDES AND NUCLEOTIDES

Product summary:

Active ingredient group (AIG) number: 0115506005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2011-08-03

Summary of Product characteristics

                                _2008-09-10/131-prisitne-english-zovirax.doc _
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Acyclovir Tablets USP, 200, 400, and 800 mg
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
September 10, 2008
SUBMISSION CONTROL NUMBER: 123012
_©_
_ 2008 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_ ZOVIRAX, WELLSTAT PAC and ZOSTAB PAC are registered trademarks,
GlaxoSmithKline Inc. _
_2008-09-10/131-prisitne-english-zovirax.doc _
_ _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND
ADMINISTRATION..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL
INFORMATION..........................
                                
                                Read the complete document
                                
                            

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