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

Treposuvi 5 mg/ml solution for infusion

Orpha-Devel Handels und Vertriebs GmbHPA1353/006/003

Main Information

Trade NameTreposuvi 5 mg/ml solution for infusion
Active SubstancesTreprostinil
Dosage FormSolution for infusion
Licence HolderOrpha-Devel Handels und Vertriebs GmbH
Licence NumberPA1353/006/003

Group Information

ATC CodeB01AC21 treprostinil


License statusAuthorised
Licence Issued07/05/2021
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 products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


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