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


Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

38 milligram(s)/millilitre Concentrate for solution for infusion

Fresenius Kabi Deutschland GmbHPA2059/039/005

Main Information

Trade NameGemcitabine 38 mg/ml Concentrate for Solution for Infusion
Active SubstancesGEMCITABINE HYDROCHLORIDE
Strength38 milligram(s)/millilitre
Dosage FormConcentrate for solution for infusion
Licence HolderFresenius Kabi Deutschland GmbH
Licence NumberPA2059/039/005

Group Information

ATC CodeL01BC Pyrimidine analogues
L01BC05 gemcitabine

Status

Authorised/WithdrawnAuthorised
Licence Issued16/01/2015
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 StatusMarketed

Documents

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