Milano Drop (DJG Care Pty Ltd)
Product Name
Milano Drop
Sponsor
ARTG
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine continues to be permitted for supply. Batches released from September 2022 must carry a corrected label with the updated medicine name (Milano Drop), updated sponsor name (DJG Care Pty Ltd) and the correct amount of Vitamin A.
Is it safe to continue using this medicine?
Yes
What action should consumers take?
None
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The label and name of the medicine implied its use for melanoma, which is a serious condition that requires diagnosis, treatment and/or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The implied reference to melanoma has the potential to lead consumers with this condition to delay access to timely medical advice or treatment, or to incorrectly use it for sun-protection, resulting in adverse outcomes.
Additionally, the amount of vitamin A in the medicine was incorrectly entered into the ARTG record and on the label. As Vitamin A can be dangerous when taken over the recommended daily limit, the correct amount is required to be included on the label and ARTG record to ensure the safe use of the medicine.
However, as the medicine has not yet been marketed, it is unlikely to pose an immediate risk to consumer health and safety.
Additionally, the amount of vitamin A in the medicine was incorrectly entered into the ARTG record and on the label. As Vitamin A can be dangerous when taken over the recommended daily limit, the correct amount is required to be included on the label and ARTG record to ensure the safe use of the medicine.
However, as the medicine has not yet been marketed, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label and ARTG record as detailed in ‘Review outcome’ above.