CO VALACYCLOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-02-2016
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Active ingredient:
VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)
Available from:
COBALT PHARMACEUTICALS COMPANY
ATC code:
J05AB11
INN (International Name):
VALACICLOVIR
Dosage:
500MG
Pharmaceutical form:
TABLET
Composition:
VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 500MG
Administration route:
ORAL
Units in package:
21/42/100/500
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDES AND NUCLEOTIDES
Product summary:
Active ingredient group (AIG) number: 0128626001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-11-12
Summary of Product characteristics
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_Page 1 of 40_
PRODUCT MONOGRAPH
PR
_CO _VALACYCLOVIR
Valacyclovir Hydrochloride Tablets
500 mg and 1000 mg valacyclovir (as valacyclovir hydrochloride)
Antiviral Agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
February 01, 2016
Control No.: 191484
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_Page 2 of 40_
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................................................
20
CLINICAL TRIALS
.........................................................................................................
21
DETAILED PHARMACOLOGY
...............
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