Royal Mom (Royal Care Pty Ltd)
Product Name
Royal Mom
Sponsor
ARTG
393870
Date of review outcome
Date cancellation takes effect
Date of publication
Jun-23
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification
What action should consumers take?
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the claims regarding pregnancy
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The safety of this medicine was not assessed as part of this review
Issues related to efficacy
The efficacy of this medicine could not be assessed as the sponsor did not provide the requested information that supports its use during pregnancy
Actions taken during the review
The TGA cancelled this medicine and withdrew permission for further supply as the sponsor did not provide the requested information
Grounds for cancellation
The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods