Enjaymo
sutimlimab
Table of contents
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
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List item
Enjaymo : EPAR - Medicine Overview (PDF/109.57 KB)
First published: 17/11/2022
EMA/778266/2022 -
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Enjaymo : EPAR - Risk Management Plan (PDF/850.07 KB)
First published: 17/11/2022
Authorisation details
Product details | |
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Name |
Enjaymo
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Agency product number |
EMEA/H/C/005776
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Active substance |
sutimlimab
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International non-proprietary name (INN) or common name |
sutimlimab
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L04AA55
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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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Sanofi B.V.
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
15/11/2022
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Contact address |
Paasheuvelweg 25 |
Product information
25/08/2023 Enjaymo - EMEA/H/C/005776 - N/0005
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).