MAFVIR

Main information

  • Trade name:
  • MAFVIR
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MAFVIR
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177001
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177001

MAFVIR famciclovir 250 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

Australia

ARTG Start Date

14/08/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MAFVIR

Product Type

Single Medicine Product

Effective date

11/02/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Famciclovir is indicated for:

òTreatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. Greatest benefit occurs if the drug

is started within 48 hours. Efficacy has not been demonstrated in patients less than 50 years of age, although the occasional younger patient with severe

herpes zoster may benefit from therapy with famciclovir. Herpes zoster infection is generally a milder condition in younger patients.

òTreatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.

òSuppression of recurrent genital herpes.

òTreatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.,Famciclovir is also indicated in immunocompromised patients

for:

òTreatment of uncomplicated herpes zoster.

òTreatment of recurrent herpes simplex.

òSuppression of recurrent herpes simplex.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

56 tablets

(S4) Prescription Only Medicine

20 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

21 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White round film coated tablets with FM on one side and 250 on the other

side

Active Ingredients

Famciclovir

250 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:02:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information