Ruconest

conestat alfa

Table of contents

Opinion

On 26 March 2020, 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 to include children from the age of 2 years and above.

For information, the full indication for Ruconest will be as follows1:

Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) 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.


1New text in bold

Key facts

Name
Ruconest
Agency product number
EMEA/H/C/001223
International non-proprietary name (INN) or common name
  • conestat alfa
Active substance
  • Recombinant human C1-inhibitor
Therapeutic area
Angioedemas, Hereditary
Date opinion adopted
26/03/2020
Company name
Pharming Group N.V.
Status
Positive
Application type
Post-authorisation

How useful was this page?

Add your rating