Daklinza

Expired

This medicine's authorisation has expired

daclatasvir

Overview

The marketing authorisation for Daklinza (daclatasvir) expired on 26 August 2019 following the decision of the marketing authorisation holder, Bristol-Myers Squibb Pharma EEIG, not to apply for a renewal of the marketing authorisation for commercial reasons. 

Daklinza was granted marketing authorisation in the European Union (EU) on 22 August 2014 for the treatment of chronic hepatitis C virus (HCV) infection in adults. The marketing authorisation was valid for 5 years. 

The European Public Assessment Report (EPAR) for Daklinza is updated to indicate that the marketing authorisation is no longer valid.

Daklinza : EPAR - Summary for the public

Reference Number: EMA/525602/2014

Daklinza : EPAR - Risk-management-plan summary

Product information

Daklinza : EPAR - Product Information

Daklinza : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Daklinza
• Active substance:
  daclatasvir dihydrochloride
• International non-proprietary name (INN) or common name:
  daclatasvir
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AP07

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/003768
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Marketing authorisation holder:
  Bristol-Myers Squibb Pharma EEIG

  Plaza 254; Blanchardstown Corporate Park 2; Dublin 15; D15 T867; Ireland

• Opinion adopted:
  26/06/2014
• Marketing authorisation issued:
  22/08/2014
• Expiry of marketing authorisation:
  26/08/2019
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Daklinza : EPAR - Procedural steps taken and scientific information after authorisation

Daklinza : EPAR - Scientific Conclusion

Daklinza-H-C-3768-A-20-0016 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/103226/2017

Initial marketing authorisation documents

Daklinza : EPAR - Public assessment report

Adopted Reference Number: EMA/419836/2014

CHMP summary of positive opinion for Daklinza

Adopted Reference Number: EMA/CHMP/372924/2014