Ultomiris

RSS

ravulizumab

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

Overview

Ultomiris is a medicine used to treat:

  • adults and children weighing at least 10 kg who have paroxysmal nocturnal haemoglobinuria (PNH), a disease in which the immune system attacks and damages red blood cells, resulting in anaemia (low red blood cell counts), thrombosis (blood clots in the blood vessels), pancytopenia (low counts of blood cells) and dark urine.
  • adults and children weighing at least 10 kg who have atypical haemolytic uraemic syndrome (aHUS), a disease in which the immune system causes damage leading to anaemia, thrombocytopenia (a decrease in the number of platelets, components that help the blood to clot) and kidney failure.
  • adults with generalised myasthenia gravis (gMG), a disease in which the immune system attacks and damages receptors at the junction between nerves and muscle cells, causing muscle weakness and tiredness

In PNH, Ultomiris is used in patients who have symptoms indicating high disease activity or who have been treated with eculizumab (another medicine for PNH and aHUS) for at least the past 6 months and have evidence that the treatment is working.

In aHUS, Ultomiris is used in patients who either have not received complement inhibitors (such as eculizumab) before or who have received eculizumab for at least 3 months and have evidence that the treatment is working.

In gMG, Ultomiris is given with other medicines in patients whose immune system produces a specific antibody (type of protein) against a target found on muscle cells, called acetylcholine receptor.

Ultomiris contains the active substance ravulizumab.

This EPAR was last updated on 23/11/2022

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
L04AA43
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
9
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

21/09/2022 Ultomiris - EMEA/H/C/004954 - II/0026

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Selective immunosuppressants

Therapeutic indication

Paroxysmal nocturnal haemoglobinuria (PNH)
Ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with 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).

Atypical haemolytic uremic syndrome (aHUS)
Ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5.1).

Generalized myasthenia gravis (gMG)
Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.

Assessment history

Changes since initial authorisation of medicine

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