CHMP adopts positive opinion to include self-administration for RUCONEST®

Friday, November 11, 2016

Pharming Group N.V. announced that following evaluation of a dossier submitted by the Company earlier this year, 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.

This recommendation will allow self-administration of RUCONEST® for acute hereditary angioedema (HAE) attacks by adolescents and adults with a new custom-designed administration kit.  

Following normal timelines after the adoption of the positive opinion by CHMP, the final decision from the European Committee is expected in January 2017. It is expected that the kits will become available for use in the various EU markets soon thereafter.

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