Starpharma Pty Ltd - VivaGel® Vaginal Gel (Fleurstat™ BV Gel)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Starpharma Pty Ltd

I, Leanne McCauley, Delegate of the Secretary to the Department of Health, on receipt of an application from Starpharma Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraph (c) are met:

1.  
   1. "For treatment of bacterial vaginosis and relief from symptoms."
   2. "For treatment and relief of bacterial vaginosis."
   3. "Fleurstat™ BV gel works to treat BV by disrupting the attachment of BV-causing bacteria to the vaginal lining."
   4. "Fleurstat™ BV gel - for the treatment of BV and relief of symptoms, including abnormal vaginal odour and discharge, helping to normalise vaginal pH, and restore the normal vaginal flora balance."
   5. "For treatment and relief of bacterial vaginosis and its symptoms including vaginal odour and discharge."
2. VivaGel® Vaginal Gel (Fleurstat™ BV Gel) (ARTG No. 295465)
3. must appear whenever any one of, or any combination of, the restricted representations is used in the IFU and the product carton.

   1. A statement to the effect:

      • See your healthcare provider if:
      • you consider that you may be at risk of an STI;
      • your symptoms persist or recur, or your condition worsens, as these symptoms may be indicative another infection, including an STI;
      • you are pregnant or plan to become pregnant, or you are breastfeeding or plan to breastfeed; you should seek advice of your healthcare provider before using Fleurstat™ BVgel.

      must appear whenever any one of, or any combination of, the restricted representations is used, irrespective of the type of advertisement.

   2. A statement to the following effect:
      • BV is associated with a characteristic 'fishy' vaginal odour and an abnormal greyish-white, thin vaginal discharge. Other common vaginal infections may be associated with intense itching or painful urination, and clumpy or frothy discharge. If you are unsure you have BV, or suspect you have a vaginal infection other than BV, please see your healthcare provider.
   3. This approval is valid only until 1 May 2019.
   4. Use of the representations is permitted on condition that the Device is available only from a pharmacy or other suitable healthcare provider.

Dated this 23rd day of May 2018

Signed and authorised by

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch