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Cozaar 12.5mg Film-coated Tablets



Organon Pharma (Ireland) LimitedPA23198/002/001

Main Information

Trade NameCozaar 12.5mg Film-coated Tablets
Active SubstancesLosartan potassium
Dosage FormFilm-coated tablet
Licence HolderOrganon Pharma (Ireland) Limited
Licence NumberPA23198/002/001

Group Information

ATC CodeC09CA Angiotensin II antagonists, plain
C09CA01 losartan

Status

License statusAuthorised
Licence Issued06/03/2009
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceCommitments The development of this product has complied with all measures in the agreed paediatric investigation plan P/9/2008. For the purpose of the application of Article 45(3) of Regulation EC (No) 1901/2006, all studies in the agreed paediatric investigation plan P/9/2008 were completed after the entry into force of that Regulation. The Summary of Product Characteristics reflects the results of studies conducted in compliance with this agreed paediatric investigation plan.
Marketing StatusMarketed

Documents

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