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Tracleer



Janssen-Cilag International NVEU/1/02/220/005

Main Information

Trade NameTracleer
Active SubstancesBosentan
Dosage FormFilm-coated tablet
Licence HolderJanssen-Cilag International NV
Licence NumberEU/1/02/220/005

Group Information

ATC CodeC02KX Other antihypertensives
C02KX01 bosentan

Status

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

Documents

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