Ruconest

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conestat alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ruconest. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ruconest.

This EPAR was last updated on 07/05/2018

Authorisation details

Product details
Name
Ruconest
Agency product number
EMEA/H/C/001223
Active substance
Recombinant human C1-inhibitor
International non-proprietary name (INN) or common name
conestat alfa
Therapeutic area (MeSH)
Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code
B06AC04
Publication details
Marketing-authorisation holder
Pharming Group N.V.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
28/10/2010
Contact address
Darwinweg 24
NL-2333 CR Leiden
The Netherlands

Product information

10/04/2018 Ruconest - EMEA/H/C/001223 - N/0046

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other haematological agents

Therapeutic indication

Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.

Assessment history

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