Icatibant Accord



This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 06/09/2021

Authorisation details

Product details
Icatibant Accord
Agency product number
Active substance
icatibant acetate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Angioedemas, Hereditary
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

16/07/2021 Icatibant Accord - EMEA/H/C/005083 -

Other EU languages available icon 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:

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

Other hematological agents

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.

Assessment history

How useful was this page?

Add your rating
1 rating
1 rating