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Deltyba



Otsuka Novel Products GmbHEU/1/13/875/001-003

Main Information

Trade NameDeltyba
Active SubstancesDelamanid
Dosage FormFilm-coated tablet
Licence HolderOtsuka Novel Products GmbH
Licence NumberEU/1/13/875/001-003

Group Information

ATC CodeJ04AK Other drugs for treatment of tuberculosis
J04AK06 delamanid

Status

License statusAuthorised
Licence Issued28/04/2014
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 products 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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