Basic Information
Icatibant Accord
Regulatory Information
EMEA/H/C/005083
July 16, 2021
May 20, 2021
1
January 25, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Icatibant Accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1 esterase inhibitor deficiency.
Overview Summary
Icatibant Accord is a medicine used to treat the symptoms of hereditary angioedema in patients aged 2 years and over. Patients with angioedema have rapid swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway. Icatibant Accord is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor’. Icatibant Accord contains the active substance icatibant and is a ‘generic medicine’. This means that Icatibant Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Firazyr.