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Paralink Six Plus Paracetamol 250 mg/5 ml oral solution



Phoenix Healthcare LtdPA1721/006/004

Main Information

Trade NameParalink Six Plus Paracetamol 250 mg/5 ml oral solution
Active SubstancesParacetamol
Dosage FormOral solution
Licence HolderPhoenix Healthcare Ltd
Licence NumberPA1721/006/004

Group Information

ATC CodeN02BE Anilides
N02BE01 paracetamol

Status

License statusAuthorised
Licence Issued31/07/2009
Legal statusProduct not subject to medical prescription
Supply StatusSupply through non-pharmacy outlets and pharmacies
Advertising StatusAdvertising to the general public
Conditions of LicenceGeneral sale in child resistant packs containing not more than 60ml of the 250mg/5ml unit dosage form. The product concerned should contain paracetamol as its only active analgesic substance and only one pack should be supplied in the course of any one retail transaction. Retail sale through pharmacies only in child resistant packs containing not more than 70ml of the 250mg/5ml unit dosage form. Not more than two such packs should be supplied in the course of any one retail transaction unless a valid prescription exists. Commitments The current stability studies will be continued to 24 months at least, with samples being tested at the 12 month and 18 month time points; any out-of-specification results will be notified to the HPRA.
Marketing StatusMarketed

Documents

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