The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an educational letter to the sponsor reminding them of their regulatory responsibilities
This medicine was targeted to check its compliance with warning statement requirements related to use during pregnancy
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.