Icatibant Accord
icatibant
Table of contents
Overview
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.
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Icatibant Accord : EPAR - Medicine overview (PDF/133 KB)
First published: 06/09/2021
EMA/308584/2021 -
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Icatibant Accord : EPAR - Risk-management-plan summary (PDF/97.93 KB)
First published: 06/09/2021
Authorisation details
Product details | |
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Name |
Icatibant Accord
|
Agency product number |
EMEA/H/C/005083
|
Active substance |
icatibant acetate
|
International non-proprietary name (INN) or common name |
icatibant
|
Therapeutic area (MeSH) |
Angioedemas, Hereditary
|
Anatomical therapeutic chemical (ATC) code |
B06AC02
|
Generic |
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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Date of issue of marketing authorisation valid throughout the European Union |
16/07/2021
|
Contact address |
Accord Healthcare S.L.U. |
Product information
16/07/2021 Icatibant Accord - EMEA/H/C/005083 -
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
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.