PMS-VALACYCLOVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Available from:

PHARMASCIENCE INC

ATC code:

J05AB11

INN (International Name):

VALACICLOVIR

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

NUCLEOSIDES AND NUCLEOTIDES

Product summary:

Active ingredient group (AIG) number: 0128626001; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-05-15

Summary of Product characteristics

_pms-VALACYCLOVIR (Valacyclovir Tablets) page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-VALACYCLOVIR
Valacyclovir tablets
Tablets, 500 mg and 1000 mg (as valacyclovir hydrochloride), oral
House Standard
Antiviral Agent
PHARMASCIENCE INC.
Date of Initial Authorization:
6111 Royalmount Ave., Suite 100
MAY 15, 2008
Montréal, Québec
H4P 2T4
Date of Revision:
MAY 10, 2023
www.pharmascience.com
Submission Control Number: 270106
_pms-VALACYCLOVIR (Valacyclovir Tablets) page 2 of 39 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2 TABLE OF CONTENTS
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2 PART I: HEALTH PROFESSIONAL INFORMATION
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4 1 INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
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