COLD

Main information

  • Trade name:
  • COLD SORE TREATMENT famciclovir 500mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLD SORE TREATMENT famciclovir 500mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212558
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212558

COLD SORE TREATMENT famciclovir 500mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

Australia

ARTG Start Date

24/07/2013

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Products

1. COLD SORE TREATMENT famciclovir 500mg tablet blister pack

Product Type

Single Medicine Product

Effective date

24/07/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients 18 years and over

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

white oval film coated tablets with FM on one side and 500 on the other

side

Active Ingredients

Famciclovir

500 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 27.11.2017 at 12:13:35 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

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Europe - EFSA - European Food Safety Authority Publications

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Is It a Cold or the Flu? Prevention, Symptoms, Treatments

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How to tell if you have a cold or the flu, and when to seek medical care.

FDA - U.S. Food and Drug Administration

16-3-2015

New management at the DHMA

New management at the DHMA

As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Anne-Marie Vangsted will continue as Director with special responsibility for the DHMA's supervision.

Danish Medicines Agency

There are no news related to this product.