Cellife Prenatal Multi (Cellife Health Products Pty Ltd)
Product Name
Cellife Prenatal Multi
Sponsor
ARTG
376978
Date of review outcome
Date cancellation takes effect
Date of publication
Dec-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 is not considered acceptable for a listed medicine
What action should consumers take?
Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label was missing the mandatory warning statement for use during pregnancy, as set out under 'What action should consumers take'. This warning statement is necessary to ensure the safe use of the medicine and to alert consumers to safety risks prior to taking the medicine. However, the medicine was not recalled following the sponsor's assurance that the medicine had not been marketed in Australia. Therefore, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of the medicine claimed the medicine is for use in pregnancy. However, this claim is not covered by the sponsor's certification that they hold evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor did not provide information to sufficiently address all of the issues. The TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (paragraph 30(2)(c) of the Act)