Infloran (Prinz-Herget Pty Ltd T/A Evidence Based Probiotics)
Product Name
Infloran
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?
Seek advice from a medical practitioner if you have been giving this medicine to preterm or sick babies, particularly to prevent necrotising enterocolitis (NEC).
Consider whether this medicine is right for you based on it potentially not working as expected in relation to relieving constipation and digestive function issues, preventing the colonisation of pathogens, improving the maturity and function of gut mucosal barrier, being antimicrobial, and anti-inflammatory.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to relieving constipation and digestive function issues, preventing the colonisation of pathogens, improving the maturity and function of gut mucosal barrier, being antimicrobial, and anti-inflammatory.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Manufacturing Documentation, Website
Issues related to safety
The websites and other advertising for this medicine contained claims regarding the conditions and populations specified in 'What actions should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional when required, which may result in adverse outcomes.
The websites and other advertising for this medicine also contained claims that this medicine was safe and without harm. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even when it is not safe or appropriate.
While advertising of this nature is unacceptable, the label and websites advised consumers to see a health professional if symptoms persisted, and the claims have been removed. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The websites and other advertising for this medicine also contained claims that this medicine was safe and without harm. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even when it is not safe or appropriate.
While advertising of this nature is unacceptable, the label and websites advised consumers to see a health professional if symptoms persisted, and the claims have been removed. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The websites and other advertising for this medicine contained claims specified in 'What action should consumers take?' above. The website also claimed that this medicine is beneficial in all infants. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor updated the websites and other advertising to correct these issues. The TGA also issued an educational letter to the sponsor.