Para Rid (Orchard St Pty Ltd)
Product Name
Para Rid
Sponsor
ARTG
Date of review outcome
Date of publication
Sep-2024
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Do not use if pregnant or likely to become pregnant
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for this medicine was missing the mandatory warning statement for the herbal ingredient Artemisia absinthium, as set out under 'What action should consumers take?'. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it. While the absence of a warning statement is unacceptable, the warning statement is included on the label, and the website has been updated. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The sponsor updated the website for this medicine to include the mandatory warning statement. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issue with this medicine, and to remind them of their regulatory responsibilities.
Additional information
This medicine was targeted to check its compliance with pregnancy warning statement requirements for Artemisia species