CO VALACYCLOVIR TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Beschikbaar vanaf:

COBALT PHARMACEUTICALS COMPANY

ATC-code:

J05AB11

INN (Algemene Internationale Benaming):

VALACICLOVIR

Dosering:

1000MG

farmaceutische vorm:

TABLET

Samenstelling:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 1000MG

Toedieningsweg:

ORAL

Eenheden in pakket:

21/30/100

Prescription-type:

Prescription

Therapeutisch gebied:

NUCLEOSIDES AND NUCLEOTIDES

Product samenvatting:

Active ingredient group (AIG) number: 0128626003; AHFS:

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2017-09-01

Productkenmerken

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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
...............