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Aspirin EC 300mg, gastro-resistant tablets

300 milligram(s) Gastro-resistant tablet

PCO Manufacturing Ltd.PA0465/057/001

Main Information

Trade NameAspirin EC 300mg, gastro-resistant tablets
Active SubstancesAcetylsalicylic acid
Strength300 milligram(s)
Dosage FormGastro-resistant tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPA0465/057/001

Group Information

ATC CodeN02BA Salicylic acid and derivatives
N02BA01 acetylsalicylic acid

Status

Authorised/WithdrawnAuthorised
Licence Issued17/07/2002
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceTo provide prior to marketing, 3 months stability data of at least three batches to the IMB for review and marketing will not occur until this has been carried out. The commitment should include that the studies of those batches will continue to shelf life, with any out of specification results being reported to the IMB. To provide a revised QP declaration prior to marketing.
Marketing StatusNot marketed

Documents

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