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

Ambrisentan Accord 5 mg film-coated tablets

Accord Healthcare Ireland Ltd.PA2315/235/001

Main Information

Trade NameAmbrisentan Accord 5 mg film-coated tablets
Active SubstancesAmbrisentan
Dosage FormFilm-coated tablet
Licence HolderAccord Healthcare Ireland Ltd.
Licence NumberPA2315/235/001

Group Information

ATC CodeC02KX Other antihypertensives
C02KX02 ambrisentan


License statusAuthorised
Licence Issued22/11/2019
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: Summary of Product Characteristics, section 4.2).
Marketing StatusMarketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

Educational Materials - Patient

« Back