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


Flucloxacillin 250 mg Capsules

250 milligram(s) Capsule

Athlone Laboratories LtdPA0298/017/001

Main Information

Trade NameFlucloxacillin 250 mg Capsules
Active SubstancesFlucloxacillin
Strength250 milligram(s)
Dosage FormCapsule
Licence HolderAthlone Laboratories Ltd
Licence NumberPA0298/017/001

Group Information

ATC CodeJ01CF Beta-lactamase resistant penicillins
J01CF05 flucloxacillin

Status

Authorised/WithdrawnAuthorised
Licence Issued14/10/2011
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceA post approval commitment has been made by Athlone Laboratories Ltd to provide an updated QP declaration following the audit of the Fresenius site of manufacture for the active ingredient Flucloxacillin sodium - Fresenius K.ABI Anti-Infectives S.R.L., Via San Leonardo 23, I-45010 Villadose, Rovigo, Italy. This updated QP declaration will be provided by way of variation to the above licences under change TypelA category A8. This will be submitted in March 2017.
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportPDF Version

Generics Information

Interchangeable ListFlucloxacillin 250 mg Capsules
Interchangeable List CodeIC0089-130-001
Interchangeable List DocumentPDF of Interchangeable List
« Back