Ultomiris

RSS

ravulizumab

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

Overview

Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH). PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney problems and blood clots in the blood vessels.

Ultomiris is used in patients who have symptoms of the disease as well as in patients who have stable blood levels of the enzyme lactate dehydrogenase (LDH), which gives an indication of how many red blood cells are being broken down. It should be used after patients have been treated with eculizumab (another medicine for PNH) for at least the past 6 months.

Ultomiris contains the active substance ravulizumab.

This EPAR was last updated on 08/08/2019

Authorisation details

Product details
Name
Ultomiris
Agency product number
EMEA/H/C/004954
Active substance
ravulizumab
International non-proprietary name (INN) or common name
ravulizumab
Therapeutic area (MeSH)
Hemoglobinuria, Paroxysmal
Anatomical therapeutic chemical (ATC) code
L04AA
Additional monitoringAdditional 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.

Publication details
Marketing-authorisation holder
Alexion Europe SAS
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
02/07/2019
Contact address

103-105 rue Anatole France
92300 Levallois-Perret
France

Product information

26/07/2019 Ultomiris - EMEA/H/C/004954 - IAIN/0001

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Pharmacotherapeutic group

Selective immunosuppressants

Therapeutic indication

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.

Assessment history

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