Enjaymo

RSS

sutimlimab

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

Overview

Enjaymo is a medicine for treating haemolytic anaemia (excess breakdown of red blood cells) in adults with cold agglutinin disease (CAD).

CAD is a rare blood disorder where the immune system (the body’s natural defence) recognises red blood cells as foreign and attacks them. This causes agglutination (clumping together) and haemolysis (disruption) of the red blood cells, resulting in low red blood cell counts and low levels of haemoglobin.

Haemolytic anaemia is rare, and Enjaymo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 February 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3161609.

Enjaymo contains the active substance sutimlimab

This EPAR was last updated on 17/11/2022

Authorisation details

Product details
Name
Enjaymo
Agency product number
EMEA/H/C/005776
Active substance
sutimlimab
International non-proprietary name (INN) or common name
sutimlimab
Therapeutic area (MeSH)
  • Hemolysis
  • Anemia, Hemolytic, Autoimmune
Anatomical therapeutic chemical (ATC) code
L04AA55
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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Genzyme Europe BV
Date of issue of marketing authorisation valid throughout the European Union
15/11/2022
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Product information

Enjaymo - EMEA/H/C/005776 -

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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

Immunosuppressants

Therapeutic indication

Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD).

Assessment history

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