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


Nurofen 200 mg coated tablets



PCO Manufacturing Ltd.PPA0465/430/002

Main Information

Trade NameNurofen 200 mg coated tablets
Active SubstancesIbuprofen
Dosage FormCoated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/430/002

Group Information

ATC CodeM01AE01 ibuprofen

Status

License statusAuthorised
Licence Issued25/08/2017
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to the general public
Conditions of LicenceSupply through pharmacies only if compliant with the following restrictions: maximum strength: 200 mg; maximum dose: 400 mg; maximum daily dose 1200 mg; maximum pack size 50, limited indications. Promotion to the public if compliant with the following restrictions: maximum strength: 200 mg; maximum dose: 400 mg; maximum daily dose 1200 mg; maximum pack size 50, limited indications.
Marketing StatusUnknown

Documents

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