MYLAN-ACYCLOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-01-2015
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Active ingredient:
ACYCLOVIR
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
J05AB01
INN (International Name):
ACYCLOVIR
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
ACYCLOVIR 200MG
Administration route:
ORAL
Units in package:
100/250
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDES AND NUCLEOTIDES
Product summary:
Active ingredient group (AIG) number: 0115506002; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-07-03
Summary of Product characteristics
_ _
_Product Monograph –Mylan_-_Acyclovir _
_Page 1 _
PRODUCT MONOGRAPH
PR
MYLAN-ACYCLOVIR
Acyclovir, USP
200, 400 and 800 mg Tablets
Manufacturer Standard
ANTIVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Control No.: 181160
DATE OF REVISION:
January 15, 2015
_ _
_Product Monograph –Mylan_-_Acyclovir _
_Page 2_
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
AVAILABILITY OF DOSAGE FORMS
........................................................................
14
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................
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