Ultomiris

ravulizumab

Table of contents

Opinion

On 30 April 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 Ultomiris. The marketing authorisation holder for this medicinal product is Alexion Europe SAS.

The CHMP adopted a new indication as follows:1

Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH):

  • in patients with haemolysis with clinical symptom(s) indicative of high disease activity.
  • in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1).

Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

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
Ultomiris
Agency product number
EMEA/H/C/004954
International non-proprietary name (INN) or common name
  • ravulizumab
Active substance
  • ravulizumab
Therapeutic area
Hemoglobinuria, Paroxysmal
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
30/04/2020
Company name
Alexion Europe SAS
Status
Positive
Application type
Post-authorisation

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