Questions & Answers
On 25 February 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ruconest. The marketing authorisation holder for this medicinal product is Pharming Group N.V.
The CHMP adopted an extension to the existing indication as follows1:
“Ruconest is indicated for treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.”
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold
|Name||Language||First published||Last updated|
|CHMP post-authorisation summary of positive opinion for Ruconest||(English only)||2016-02-26|
|INN or common name|
|Therapeutic area||Angioedemas, Hereditary|
|Date opinion adopted||25/02/2016|
Pharming Group N.V.
|Application type||Post authorisation|