🇪🇺 Daclatasvir Zeta in European Union

EMA authorised Daclatasvir Zeta on 22 August 2014

Marketing authorisation

EMA — authorised 22 August 2014

  • Application: EMEA/H/C/003768
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Daklinza
  • Indication: Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For HCV genotype specific activity, see sections 4.4 and 5.1.
  • Pathway: accelerated assessment
  • Status: withdrawn

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Daclatasvir Zeta in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Daclatasvir Zeta approved in European Union?

Yes. EMA authorised it on 22 August 2014.

Who is the marketing authorisation holder for Daclatasvir Zeta in European Union?

Bristol-Myers Squibb Pharma EEIG holds the EU marketing authorisation.