PHARMACY CHOICE FAMCICLOVIR ONCE 500 mg tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
famciclovir
Available from:
Neo Health (OTC) Pty Ltd
Authorization status:
Registered
Authorization number:
351701

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Public Summary

Summary for ARTG Entry:

351701

PHARMACY CHOICE FAMCICLOVIR ONCE 500 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Neo Health (OTC) Pty Ltd

Postal Address

3/380 Pennant Hills Road, Pennant Hills, NSW, 2120

Australia

ARTG Start Date

14/12/2020

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 . PHARMACY CHOICE FAMCICLOVIR ONCE 500 mg tablet blister pack

Product Type

Single Medicine Product

Effective Date

14/12/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults aged 18 years and over.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/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, coated tablets debossed with FM on one side and 500 on the other side

Active Ingredients

famciclovir

500 mg

Other Ingredients (Excipients)

copovidone

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:29:10 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

crospovidone

hypromellose

macrogol 8000

microcrystalline cellulose

polydextrose

purified water

silicon dioxide

sodium stearylfumarate

titanium dioxide

triethyl citrate

© 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 2 of

Produced at 11.01.2021 at 08:29:10 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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