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Nurofen Plus Tablets Ibuprofen 200 mg Codeine Phosphate Hemihydrate 12.8 mg



PCO Manufacturing Ltd.PPA0465/410/001

Main Information

Trade NameNurofen Plus Tablets Ibuprofen 200 mg Codeine Phosphate Hemihydrate 12.8 mg
Active SubstancesIbuprofen
Codeine phosphate hemihydrate
Dosage FormFilm-coated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/410/001

Group Information

ATC CodeN02AJ Opioids in combination with non-opioid analgesics
N02AJ08 codeine and ibuprofen

Status

License statusAuthorised
Licence Issued29/05/2015
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceProduct not subject to medical prescription, supply through pharmacies only and promotion to the healthcare professionals only subject to the following restrictions: For ibuprofen: maximum strength 200 mg, maximum dose: 400 mg, maximum daily dose 1200 mg, limited indications. For use in adults and children not under 12 years. For codeine: maximum dose equivalent of 20 mg. Packs containing more than 24 tablets are prescription only.
Marketing StatusUnknown

Documents

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