CHMP adopts positive opinion to include self-administration for RUCONEST®
Pharming announces the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an extension to the terms of the marketing authorisation for RUCONEST® to the European Commission.
- Home-administration recommended to be included in label for use of RUCONEST®, with a new custom-designed administration kit
- Final decision from European Commission anticipated in January 2017
- Administration kits expected to be available in EU markets soon thereafter
- EU approval of self-administration is further to US approval received in 2014
This EU label change proposal is yet another testament to RUCONEST®’s well-established and favorable safety profile.- Dr. Bruno Giannetti