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Paralief Night Film-coated Tablets Paracetamol 500 mg Diphenhydramine hydrochloride 25 mg



Clonmel Healthcare LtdPA0126/338/001

Main Information

Trade NameParalief Night Film-coated Tablets Paracetamol 500 mg Diphenhydramine hydrochloride 25 mg
Active SubstancesParacetamol
Diphenhydramine hydrochloride
Dosage FormFilm-coated tablet
Licence HolderClonmel Healthcare Ltd
Licence NumberPA0126/338/001

Group Information

ATC CodeN02BE Anilides
N02BE01 paracetamol
R06AA Aminoalkyl ethers
R06AA02 diphenhydramine

Status

License statusAuthorised
Licence Issued06/01/2017
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to the general public
Conditions of LicenceRetail sale through pharmacies only in blister packs containing not more than 24 unit dosage forms. Not more than two such packs should be supplied in the course of any one retail transaction unless a valid prescription exists. Packs containing more than 24 unit dosage forms may be supplied to pharmacies for use by pharmacists provided the label states that they are for dispensing purposes only. Packs containing more than 50 unit dosage forms are prescription only. promotion to the general public for packs containing not more than 24 unit dosage forms. Promotion to healthcare professionals only for packs containing more than 24 unit dosage forms.
Marketing StatusMarketed

Documents

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