Overview

The marketing authorisation for Daklinza has expired following the marketing-authorisation holder’s decision not to pursue the renewal of the marketing authorisation.

Daklinza : EPAR - Summary for the public

Reference Number: EMA/525602/2014

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български (BG) (628.18 KB - PDF)

First published: 15/09/2014
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español (ES) (543.49 KB - PDF)

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čeština (CS) (609.58 KB - PDF)

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dansk (DA) (542.71 KB - PDF)

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Deutsch (DE) (546.46 KB - PDF)

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eesti keel (ET) (540.28 KB - PDF)

First published: 15/09/2014
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ελληνικά (EL) (631.92 KB - PDF)

First published: 15/09/2014
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français (FR) (544.71 KB - PDF)

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hrvatski (HR) (564.65 KB - PDF)

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italiano (IT) (542.93 KB - PDF)

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latviešu valoda (LV) (607.76 KB - PDF)

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lietuvių kalba (LT) (568.71 KB - PDF)

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magyar (HU) (602.84 KB - PDF)

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Malti (MT) (647.47 KB - PDF)

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Nederlands (NL) (543.11 KB - PDF)

First published: 15/09/2014
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polski (PL) (608.14 KB - PDF)

First published: 15/09/2014
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português (PT) (543.83 KB - PDF)

First published: 15/09/2014
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română (RO) (568.41 KB - PDF)

First published: 15/09/2014
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slovenčina (SK) (608.8 KB - PDF)

First published: 15/09/2014
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slovenščina (SL) (601.12 KB - PDF)

First published: 15/09/2014
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Suomi (FI) (542.26 KB - PDF)

First published: 15/09/2014
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svenska (SV) (542.83 KB - PDF)

First published: 15/09/2014
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Daklinza : EPAR - Risk-management-plan summary

English (EN) (751.3 KB - PDF)

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Product information

Daklinza : EPAR - Product Information

English (EN) (1.48 MB - PDF)

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български (BG) (2.6 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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español (ES) (1.52 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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čeština (CS) (2.17 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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dansk (DA) (1.5 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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Deutsch (DE) (1.56 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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eesti keel (ET) (1.5 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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ελληνικά (EL) (2.72 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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français (FR) (1.55 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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hrvatski (HR) (1.51 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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íslenska (IS) (1.5 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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italiano (IT) (1.52 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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latviešu valoda (LV) (2.2 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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lietuvių kalba (LT) (1.51 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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magyar (HU) (2.2 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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Malti (MT) (2.2 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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Nederlands (NL) (1.53 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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norsk (NO) (1.49 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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polski (PL) (2.23 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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português (PT) (1.51 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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română (RO) (1.54 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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slovenčina (SK) (2.18 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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slovenščina (SL) (2.15 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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Suomi (FI) (1.51 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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svenska (SV) (1.5 MB - PDF)

First published: 15/09/2014Last updated: 22/08/2019
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Latest procedure affecting product information: IA/0034

24/07/2019

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Daklinza : EPAR - All Authorised presentations

English (EN) (499.41 KB - PDF)

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български (BG) (538.09 KB - PDF)

First published: 15/09/2014
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español (ES) (480.15 KB - PDF)

First published: 15/09/2014
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čeština (CS) (519.28 KB - PDF)

First published: 15/09/2014
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dansk (DA) (479.99 KB - PDF)

First published: 15/09/2014
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Deutsch (DE) (500.02 KB - PDF)

First published: 15/09/2014
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eesti keel (ET) (503.01 KB - PDF)

First published: 15/09/2014
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ελληνικά (EL) (538.57 KB - PDF)

First published: 15/09/2014
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français (FR) (502.55 KB - PDF)

First published: 15/09/2014
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hrvatski (HR) (522.16 KB - PDF)

First published: 15/09/2014
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íslenska (IS) (480.79 KB - PDF)

First published: 15/09/2014
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italiano (IT) (479.78 KB - PDF)

First published: 15/09/2014
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latviešu valoda (LV) (531.41 KB - PDF)

First published: 15/09/2014
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lietuvių kalba (LT) (517.54 KB - PDF)

First published: 15/09/2014
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magyar (HU) (530.57 KB - PDF)

First published: 15/09/2014
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Malti (MT) (506.8 KB - PDF)

First published: 15/09/2014
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Nederlands (NL) (479.41 KB - PDF)

First published: 15/09/2014
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norsk (NO) (480.09 KB - PDF)

First published: 15/09/2014
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polski (PL) (522.36 KB - PDF)

First published: 15/09/2014
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português (PT) (484.19 KB - PDF)

First published: 15/09/2014
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română (RO) (494 KB - PDF)

First published: 15/09/2014
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slovenčina (SK) (522.76 KB - PDF)

First published: 15/09/2014
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slovenščina (SL) (521.74 KB - PDF)

First published: 15/09/2014
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Suomi (FI) (479.66 KB - PDF)

First published: 15/09/2014
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svenska (SV) (502.37 KB - PDF)

First published: 15/09/2014
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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
Revision
15

Assessment history

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

English (EN) (722.28 KB - PDF)

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Daklinza : EPAR - Scientific Conclusion

English (EN) (538.81 KB - PDF)

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български (BG) (687.45 KB - PDF)

First published: 10/03/2017
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español (ES) (530.79 KB - PDF)

First published: 10/03/2017
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čeština (CS) (637.34 KB - PDF)

First published: 10/03/2017
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dansk (DA) (532.07 KB - PDF)

First published: 10/03/2017
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Deutsch (DE) (542.71 KB - PDF)

First published: 10/03/2017
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eesti keel (ET) (528.43 KB - PDF)

First published: 10/03/2017
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ελληνικά (EL) (698.83 KB - PDF)

First published: 10/03/2017
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français (FR) (530.89 KB - PDF)

First published: 10/03/2017
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hrvatski (HR) (572.64 KB - PDF)

First published: 10/03/2017
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italiano (IT) (538.07 KB - PDF)

First published: 10/03/2017
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latviešu valoda (LV) (664.34 KB - PDF)

First published: 10/03/2017
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lietuvių kalba (LT) (575.28 KB - PDF)

First published: 10/03/2017
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magyar (HU) (616.83 KB - PDF)

First published: 10/03/2017
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Malti (MT) (649.44 KB - PDF)

First published: 10/03/2017
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Nederlands (NL) (537.08 KB - PDF)

First published: 10/03/2017
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polski (PL) (648.49 KB - PDF)

First published: 10/03/2017
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português (PT) (538.2 KB - PDF)

First published: 10/03/2017
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română (RO) (576.84 KB - PDF)

First published: 10/03/2017
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slovenčina (SK) (631.53 KB - PDF)

First published: 10/03/2017
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slovenščina (SL) (650.63 KB - PDF)

First published: 10/03/2017
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Suomi (FI) (528.94 KB - PDF)

First published: 10/03/2017
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svenska (SV) (536.57 KB - PDF)

First published: 10/03/2017
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Daklinza-H-C-3768-A-20-0016 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/103226/2017

English (EN) (955.08 KB - PDF)

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Daklinza : EPAR - Public assessment report

AdoptedReference Number: EMA/419836/2014

English (EN) (5.38 MB - PDF)

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CHMP summary of positive opinion for Daklinza

AdoptedReference Number: EMA/CHMP/372924/2014

English (EN) (522.48 KB - PDF)

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More information on Daklinza

Public statement on Daklinza: Expiry of the marketing authorisation in the European Union

Reference Number: EMA/476687/2019

English (EN) (65.26 KB - PDF)

First published:
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