MOBICOSA (Natural Health NZ 2002 Ltd)
Product Name
MOBICOSA
Sponsor
ARTG
Date of review outcome
Date of publication
Mar-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, follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been taking this medicine to relieve rheumatoid arthritis, arthritis, arthritic pain, joint inflammation or stiffness, bowel disorders, skin conditions, asthma or stomach ulcers.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the conditions described above, as well as in maintaining general wellbeing, as a natural pain reliever and anti-inflammatory, and in the rejuvenation of cartilage and connective tissues of the joints.
Always read the label and follow the directions for use.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the conditions described above, as well as in maintaining general wellbeing, as a natural pain reliever and anti-inflammatory, and in the rejuvenation of cartilage and connective tissues of the joints.
Always read the label and follow the directions for use.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for this medicine contained claims specified in 'What action 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.
In addition, the website did not display the mandatory warning statement 'Always read the label and follow the directions for use'.
While advertising of this nature and the absence of a warning statement is unacceptable, the claims have been removed from the website and the warning statement has been added. In addition, the website and label for this medicine advised consumers to talk to their doctor or healthcare practitioner if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
In addition, the website did not display the mandatory warning statement 'Always read the label and follow the directions for use'.
While advertising of this nature and the absence of a warning statement is unacceptable, the claims have been removed from the website and the warning statement has been added. In addition, the website and label for this medicine advised consumers to talk to their doctor or healthcare practitioner if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this medicine contained claims specified in 'What action should consumers take?' above. 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 website to include the required statement and correct the issues.