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


Ratiograstim 30 MIU/0.5 ml solution for injection

30/0.5 MU/ml Solution injection or concentrate for solution infusion

Ratiopharm GmbHEU/1/08/444/1-4

Main Information

Trade NameRatiograstim 30 MIU/0.5 ml solution for injection
Active SubstancesFilgrastim
Strength30/0.5 MU/ml
Dosage FormSolution injection or concentrate for solution infusion
Licence HolderRatiopharm GmbH
Licence NumberEU/1/08/444/1-4

Group Information

ATC CodeL03AA Colony stimulating factors
L03AA02 filgrastim

Status

Authorised/WithdrawnAuthorised
Licence Issued15/09/2008
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 Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back