Ultra Nature Selituss Infant Chesty Cough Relief (Selima Pharmaceuticals)
Product Name
Ultra Nature Selituss Infant Chesty Cough Relief
Sponsor
ARTG
321546
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
No, continued use is not recommended as its safety has not been demonstrated
What action should consumers take?
Be aware that the medicine may contain levels of emetine that are unacceptable for a listed medicine. Also, the medicine may develop microbial growth when used and stored as recommended. Seek advice from your doctor if you have been taking the medicine.
Consider whether the medicine is right for you, as the medicine may not work as expected in relation to the activity of the herbal ingredient Thymus vulgaris.
Consider whether the medicine is right for you, as the medicine may not work as expected in relation to the activity of the herbal ingredient Thymus vulgaris.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The medicine contains the herbal ingredient Hedera helix which may contain emetine. There are quantity restrictions in place for emetine to ensure the safe use of listed medicines. The sponsor did not hold sufficient evidence to support their certification that the medicine complied with safety limits for emetine.
The medicine uses a liquid dropper to allow multiple doses to be taken from a single bottle. The sponsor did not hold sufficient evidence that the medicine had adequate protection from microbial contamination during storage and use.
Whilst these issues are not acceptable for a listed medicine, the medicine was not supplied in Australia and is therefore unlikely to pose a risk to Australian consumer health and safety.
The medicine uses a liquid dropper to allow multiple doses to be taken from a single bottle. The sponsor did not hold sufficient evidence that the medicine had adequate protection from microbial contamination during storage and use.
Whilst these issues are not acceptable for a listed medicine, the medicine was not supplied in Australia and is therefore unlikely to pose a risk to Australian consumer health and safety.
Issues related to efficacy
The medicine uses a liquid dropper to allow multiple doses to be taken from a single bottle. The sponsor did not provide information to demonstrate that the liquid dropper delivered consistent dosing of the medicine. This can potentially prevent accurate doses of the medicine from being measured and therefore affect the efficacy of the medicine.
The label and website for the medicine imply that the herbal ingredient Thymus vulgaris is an active ingredient. However, Thymus vulgaris is not an active ingredient in this medicine and as such no therapeutic benefits should be expected from this ingredient.
The label and website for the medicine imply that the herbal ingredient Thymus vulgaris is an active ingredient. However, Thymus vulgaris is not an active ingredient in this medicine and as such no therapeutic benefits should be expected from this ingredient.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.