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Bosentan Zentiva 62.5 mg film-coated tablets

Zentiva k.s.PA1701/011/001

Main Information

Trade NameBosentan Zentiva 62.5 mg film-coated tablets
Active SubstancesBosentan monohydrate
Dosage FormFilm-coated tablet
Licence HolderZentiva k.s.
Licence NumberPA1701/011/001

Group Information

ATC CodeC02KX01 bosentan


License statusAuthorised
Licence Issued23/02/2024
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 StatusNot marketed


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