FAMVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-02-2020
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Active ingredient:
FAMCICLOVIR
Available from:
ATNAHS PHARMA UK LIMITED
ATC code:
J05AB09
INN (International Name):
FAMCICLOVIR
Dosage:
500MG
Pharmaceutical form:
TABLET
Composition:
FAMCICLOVIR 500MG
Administration route:
ORAL
Units in package:
21
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDES AND NUCLEOTIDES
Product summary:
Active ingredient group (AIG) number: 0127885002; AHFS:
Authorization status:
APPROVED
Authorization date:
2001-01-18
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
FAMVIR
®
(famciclovir)
125mg, 250 mg and 500 mg film-coated Tablets
ANTIVIRAL AGENT
Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road
Basildon, Essex
United Kingdom, SS14 3FR
DATE OF REVISION:
February 21, 2020
SUBMISSION CONTROL NO.: 234680
FAMVIR is a registered trademark
Page 2 of 31
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
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
18
TOXICOLOGY
.................................................
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