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Gilead Sciences Ireland UCEU/1/14/958/001-002

Main Information

Trade NameHarvoni
Active SubstancesSofosbuvir
Dosage FormFilm-coated tablet
Licence HolderGilead Sciences Ireland UC
Licence NumberEU/1/14/958/001-002

Group Information

ATC CodeJ05AX Other antivirals
J05AX65 sofosbuvir and ledipasvir


License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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