GRIPP-HEEL (Brauer Professional Pty Ltd)
Product Name
GRIPP-HEEL
Sponsor
ARTG
62225
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply. Batches released from 30 June 2020 must carry a corrected label with the warning statement ‘Adults only’.
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Do not administer this medicine to children under the age of 18 years. Seek advice from a suitably qualified health practitioner if you have been doing so.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Laboratory Results, Manufacturing Documentation
Issues related to safety
The medicine contains a herbal ingredient (Aconitum napellus) in an amount which is only allowed for use in listed medicines in adults. However, the label of the medicine lacked a warning statement that the medicine should only be used in adults. These restrictions are in place to ensure the safe use of listed medicines. However, current data indicates that the amount of Aconitum napellus in the medicine is unlikely to pose an immediate safety risk to children.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label of the medicine to include the warning statement ‘Adults only’.
Additional information
This medicine was targeted to check its compliance with quantity and labelling requirements related to the ingredient Aconitum spp.