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


Daptomycin Xellia 500 mg powder for solution for injection/infusion



Xellia Pharmaceuticals ApSPA1982/003/002

Main Information

Trade NameDaptomycin Xellia 500 mg powder for solution for injection/infusion
Active SubstancesDaptomycin
Dosage FormPowder for solution for injection/infusion
Licence HolderXellia Pharmaceuticals ApS
Licence NumberPA1982/003/002

Group Information

ATC CodeJ01XX Other antibacterials
J01XX09 daptomycin

Status

License statusAuthorised
Licence Issued15/09/2017
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusNot marketed

Documents

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