BW2017 schreef op 22 december 2020 23:35:www.pharming.com/nl/nieuws
Press releaseDecember 22
Pharming Group N.V. 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
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''This EU label change proposal is yet another testament to RUCONEST®’s well-established and favorable safety profile.''
- BRUNO GIANNETTI - COO
( Test staat er nog bij, het staat wel onder nieuwsberichten en staat er net pas op .. ze zijn dus ergens mee bezig!)