The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Icatibant Accord



Accord Healthcare S.L.U.EU/1/21/1567/001-002

Main Information

Trade NameIcatibant Accord
Active SubstancesIcatibant
Dosage FormSolution for infusion in pre-filled syringe
Licence HolderAccord Healthcare S.L.U.
Licence NumberEU/1/21/1567/001-002

Group Information

ATC CodeB06AC02 icatibant

Status

License statusAuthorised
Licence Issued16/07/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) .
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back