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


Gadovist 1.0 mmol/ml solution for injection



Bayer LimitedPA1410/018/003

Main Information

Trade NameGadovist 1.0 mmol/ml solution for injection
Active SubstancesGadobutrol
Dosage FormSolution for injection
Licence HolderBayer Limited
Licence NumberPA1410/018/003

Group Information

ATC CodeV08CA Paramagnetic contrast media
V08CA09 gadobutrol

Status

License statusAuthorised
Licence Issued08/12/2000
Legal statusProduct subject to Restricted Prescription (C)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceRestricted to hospital dispensing.
Marketing StatusNot marketed

Documents

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