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Magzorb Sleep (Pharmacy Healthcare Pty Ltd)

Product Name
Magzorb Sleep
Sponsor
Pharmacy Healthcare Pty Ltd
ARTG details
Date of review outcome
Date of publication
Sep-2025
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?
In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
An e-commerce webpage for this medicine was missing the mandatory warning statement for Valeriana officinalis, as set out under 'what actions should consumers take'. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine.
While this omission is unacceptable, the warning statement is included on the label, and the webpage has been updated. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issue with this medicine's e-commerce webpage. The sponsor updated the webpage to correct the issue.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to Valerian ingredients