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DAKLINZA

90 Milligram Film Coated Tablet

Bristol-Myers Squibb Pharma EEIGEU/1/14/939/005-006

Main Information

Trade NameDAKLINZA
Active SubstancesDECLATASVIR DIHYDROCHLORIDE (BMS-790052-05)
Strength90 Milligram
Dosage FormFilm Coated Tablet
Licence HolderBristol-Myers Squibb Pharma EEIG
Licence NumberEU/1/14/939/005-006

Group Information

ATC CodeJ05AP07 Daclatasvir

Status

Authorised/WithdrawnAuthorised
Licence Issued24/06/2016
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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