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Flucloxacillin 250 mg Capsules



Athlone Pharmaceuticals LimitedPA1418/016/001

Main Information

Trade NameFlucloxacillin 250 mg Capsules
Active SubstancesFlucloxacillin
Dosage FormCapsule, hard
Licence HolderAthlone Pharmaceuticals Limited
Licence NumberPA1418/016/001

Group Information

ATC CodeJ01CF Beta-lactamase resistant penicillins
J01CF05 flucloxacillin

Status

License statusAuthorised
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
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