Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.
This risk minimisation material is a condition of the marketing authorisation. This checklist includes information on the ozanimod treatment initiation criteria (including re-initiation); monitoring parameters prior to, during and after treatment with ozanimod and counselling points for patients and pregnancy prevention for women of childbearing potential.
For Healthcare Professionals
This risk minimisation material is a condition of the marketing authorisation. This guide should be provided to patients, or caregivers of patients, receiving treatment with ozanimod as it provides important information including what patients need to be aware of before they start taking ozanimod, the signs and symptoms of important side effects they need to look out for during treatment and how to report side effects.
This risk minimisation material is a condition of the marketing authorisation. This card should be provided to women of childbearing potential receiving treatment with ozanimod. It contains information on the potential risks if ozanimod is used during pregnancy, how to minimise these risks through pregnancy prevention and what the patient should do if they become pregnant while on treatment with ozanimod.