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EMA Product

Enjaymo

Product approved by European Medicines Agency (EU)

Basic Information

Enjaymo

Regulatory Information

EMEA/H/C/005776

Authorised

November 15, 2022

September 15, 2022

6

April 8, 2024

Company Information

France

Tour Hekla 52 Avenue Du General De Gaulle 92800 Puteaux

RECORDATI RARE DISEASES

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

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

Overview Summary

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. Enjaymo contains the active substance sutimlimab

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