Regulatory Approvals

United States: The U.S. FDA approved the EMPAVELI^® Injector combination product, based on enFuse^® technology, for at-home self-administration with a specific drug.

European Union: The enFuse^® On-Body Delivery System (OBDS) including both the Syringe Transfer (ST) base and Vial Transfer (VT) base received CE Mark approval under the European Union Medical Device Regulation (EU MDR) for HCP and layperson use in-clinic or at-home.

United Kingdom: The enFuse^® On-Body Delivery System (OBDS) including both the Syringe Transfer (ST) base and Vial Transfer (VT) base has been registered with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) for HCP and layperson use in-clinic or at-home.

Brazil: The enFuse^® System (Syringe and Vial Transfer) has been registered with the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ANVISA) for HCP and layperson use in-clinic or at-home.