FAVIC
Main information
- Trade name:
- FAVIC FOR COLD SORES famciclovir 500 mg tablet blister pack
- Active ingredient:
- Famciclovir
- Available from:
- Arrow Pharma Pty Ltd
- INN (International Name):
- Famciclovir
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 212115
- Last update:
- 09-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
212115
FAVIC FOR COLD SORES famciclovir 500 mg tablet blister pack
ARTG entry for
Medicine Registered
Sponsor
Arrow Pharma Pty Ltd
Postal Address
15 - 17 Chapel Street,Cremorne, VIC, 3121
Australia
ARTG Start Date
11/07/2013
Product category
Medicine
Status
Active
Approval area
Non-Prescription Medicines
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. FAVIC FOR COLD SORES famciclovir 500 mg tablet blister pack
Product Type
Single Medicine Product
Effective date
31/10/2016
Warnings
No Warnings included on Record
Standard Indications
Specific Indications
Favic for Cold Sores is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults aged 18 years and over.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Blister Pack
PVC/PVDC/Al
3 Years
Store below 25
degrees Celsius
Not recorded
Not recorded
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 to off-white, round tablet with 'FC 500' on one side and blank 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 12:36:26 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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
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