Daklinza
Expired
This medicine's authorisation has expired
daclatasvir
MedicineHumanExpired
- Application under evaluation
- CHMP opinion
- European Commission decision
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The European Public Assessment Report (EPAR) for Daklinza is updated to indicate that the marketing authorisation is no longer valid.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
English (EN) (545.44 KB - PDF)
First published:
български (BG) (628.18 KB - PDF)
First published: 15/09/2014
español (ES) (543.49 KB - PDF)
First published: 15/09/2014
čeština (CS) (609.58 KB - PDF)
First published: 15/09/2014
dansk (DA) (542.71 KB - PDF)
First published: 15/09/2014
Deutsch (DE) (546.46 KB - PDF)
First published: 15/09/2014
eesti keel (ET) (540.28 KB - PDF)
First published: 15/09/2014
ελληνικά (EL) (631.92 KB - PDF)
First published: 15/09/2014
français (FR) (544.71 KB - PDF)
First published: 15/09/2014
hrvatski (HR) (564.65 KB - PDF)
First published: 15/09/2014
italiano (IT) (542.93 KB - PDF)
First published: 15/09/2014
latviešu valoda (LV) (607.76 KB - PDF)
First published: 15/09/2014
lietuvių kalba (LT) (568.71 KB - PDF)
First published: 15/09/2014
magyar (HU) (602.84 KB - PDF)
First published: 15/09/2014
Malti (MT) (647.47 KB - PDF)
First published: 15/09/2014
Nederlands (NL) (543.11 KB - PDF)
First published: 15/09/2014
polski (PL) (608.14 KB - PDF)
First published: 15/09/2014
português (PT) (543.83 KB - PDF)
First published: 15/09/2014
română (RO) (568.41 KB - PDF)
First published: 15/09/2014
slovenčina (SK) (608.8 KB - PDF)
First published: 15/09/2014
slovenščina (SL) (601.12 KB - PDF)
First published: 15/09/2014
Suomi (FI) (542.26 KB - PDF)
First published: 15/09/2014
svenska (SV) (542.83 KB - PDF)
First published: 15/09/2014
Daklinza : EPAR - Risk-management-plan summary
English (EN) (751.3 KB - PDF)
First published: Last updated:
Product information
Daklinza : EPAR - Product Information
English (EN) (1.48 MB - PDF)
First published: Last updated:
български (BG) (2.6 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
español (ES) (1.52 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
čeština (CS) (2.17 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
dansk (DA) (1.5 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
Deutsch (DE) (1.56 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
eesti keel (ET) (1.5 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
ελληνικά (EL) (2.72 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
français (FR) (1.55 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
hrvatski (HR) (1.51 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
íslenska (IS) (1.5 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
italiano (IT) (1.52 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
latviešu valoda (LV) (2.2 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
lietuvių kalba (LT) (1.51 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
magyar (HU) (2.2 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
Malti (MT) (2.2 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
Nederlands (NL) (1.53 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
norsk (NO) (1.49 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
polski (PL) (2.23 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
português (PT) (1.51 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
română (RO) (1.54 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
slovenčina (SK) (2.18 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
slovenščina (SL) (2.15 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
Suomi (FI) (1.51 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
svenska (SV) (1.5 MB - PDF)
First published: 15/09/2014Last updated: 22/08/2019
Latest procedure affecting product information:
IA/0034
24/07/2019
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)
First published:
български (BG) (538.09 KB - PDF)
First published: 15/09/2014
español (ES) (480.15 KB - PDF)
First published: 15/09/2014
čeština (CS) (519.28 KB - PDF)
First published: 15/09/2014
dansk (DA) (479.99 KB - PDF)
First published: 15/09/2014
Deutsch (DE) (500.02 KB - PDF)
First published: 15/09/2014
eesti keel (ET) (503.01 KB - PDF)
First published: 15/09/2014
ελληνικά (EL) (538.57 KB - PDF)
First published: 15/09/2014
français (FR) (502.55 KB - PDF)
First published: 15/09/2014
hrvatski (HR) (522.16 KB - PDF)
First published: 15/09/2014
íslenska (IS) (480.79 KB - PDF)
First published: 15/09/2014
italiano (IT) (479.78 KB - PDF)
First published: 15/09/2014
latviešu valoda (LV) (531.41 KB - PDF)
First published: 15/09/2014
lietuvių kalba (LT) (517.54 KB - PDF)
First published: 15/09/2014
magyar (HU) (530.57 KB - PDF)
First published: 15/09/2014
Malti (MT) (506.8 KB - PDF)
First published: 15/09/2014
Nederlands (NL) (479.41 KB - PDF)
First published: 15/09/2014
norsk (NO) (480.09 KB - PDF)
First published: 15/09/2014
polski (PL) (522.36 KB - PDF)
First published: 15/09/2014
português (PT) (484.19 KB - PDF)
First published: 15/09/2014
română (RO) (494 KB - PDF)
First published: 15/09/2014
slovenčina (SK) (522.76 KB - PDF)
First published: 15/09/2014
slovenščina (SL) (521.74 KB - PDF)
First published: 15/09/2014
Suomi (FI) (479.66 KB - PDF)
First published: 15/09/2014
svenska (SV) (502.37 KB - PDF)
First published: 15/09/2014
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 useTherapeutic 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
Daklinza : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (722.28 KB - PDF)
First published: Last updated:
Daklinza : EPAR - Scientific Conclusion
English (EN) (538.81 KB - PDF)
First published:
български (BG) (687.45 KB - PDF)
First published: 10/03/2017
español (ES) (530.79 KB - PDF)
First published: 10/03/2017
čeština (CS) (637.34 KB - PDF)
First published: 10/03/2017
dansk (DA) (532.07 KB - PDF)
First published: 10/03/2017
Deutsch (DE) (542.71 KB - PDF)
First published: 10/03/2017
eesti keel (ET) (528.43 KB - PDF)
First published: 10/03/2017
ελληνικά (EL) (698.83 KB - PDF)
First published: 10/03/2017
français (FR) (530.89 KB - PDF)
First published: 10/03/2017
hrvatski (HR) (572.64 KB - PDF)
First published: 10/03/2017
italiano (IT) (538.07 KB - PDF)
First published: 10/03/2017
latviešu valoda (LV) (664.34 KB - PDF)
First published: 10/03/2017
lietuvių kalba (LT) (575.28 KB - PDF)
First published: 10/03/2017
magyar (HU) (616.83 KB - PDF)
First published: 10/03/2017
Malti (MT) (649.44 KB - PDF)
First published: 10/03/2017
Nederlands (NL) (537.08 KB - PDF)
First published: 10/03/2017
polski (PL) (648.49 KB - PDF)
First published: 10/03/2017
português (PT) (538.2 KB - PDF)
First published: 10/03/2017
română (RO) (576.84 KB - PDF)
First published: 10/03/2017
slovenčina (SK) (631.53 KB - PDF)
First published: 10/03/2017
slovenščina (SL) (650.63 KB - PDF)
First published: 10/03/2017
Suomi (FI) (528.94 KB - PDF)
First published: 10/03/2017
svenska (SV) (536.57 KB - PDF)
First published: 10/03/2017
Daklinza-H-C-3768-A-20-0016 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/103226/2017
English (EN) (955.08 KB - PDF)
First published:
Daklinza : EPAR - Public assessment report
AdoptedReference Number: EMA/419836/2014
English (EN) (5.38 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Daklinza
AdoptedReference Number: EMA/CHMP/372924/2014
English (EN) (522.48 KB - PDF)
First published: Last updated:
News on Daklinza
Related content
- Clinical data (extension X/0013)
More information on Daklinza
- EMEA-001191-PIP01-11-M03 - paediatric investigation plan
- Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free) - referral
- A study to evaluate the risk of de novo hepatocellular carcinoma in patients with compensated cirrhosis treated with direct-acting antivirals for chronic hepatitis C (De Novo DAA PASS) - post-authorisation study
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