- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Smpc.
- Pregnancy and breastfeeding.
- Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
- Uterine, cervical, ovarian or breast cancer.
- Underlying hepatic disorder.
In order to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures, a patient card is to be provided in each package of Esmya. Click here to download it.
Reference 3 – Esmya® SmPC. May 2018.