Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Daklinza   
Auth. number : EU/1/14/939
Active substance : daclatasvir
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AX - Other antivirals
Chemical substance: J05AX14 - daclatasvir
(See WHO ATC Index)
Indication: Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/08/2014 Centralised - Authorisation EMEA/H/C/3768 (2014)6097 of 22/08/2014
03/10/2014 Centralised - Variation EMEA/H/C/3768/IA/1
Updated with Decision(2015)6269 of 08/09/2015
23/04/2015 Centralised - Variation EMEA/H/C/3768/II/2
Updated with Decision(2015)6269 of 08/09/2015
19/06/2015 Centralised - Variation EMEA/H/C/3768/IB/9
Updated with Decision(2015)6269 of 08/09/2015
23/07/2015 Centralised - Variation EMEA/H/C/3768/II/7/G
Updated with Decision(2015)6269 of 08/09/2015
30/07/2015 Centralised - Variation EMEA/H/C/3768/II/5
Updated with Decision(2016)629 of 28/01/2016
10/09/2015 Centralised - 2-Monthly update EMEA/H/C/3768/II/4 (2015)6269 of 08/09/2015
24/09/2015 Centralised - Variation EMEA/H/C/3768/II/8
Updated with Decision(2016)629 of 28/01/2016
01/02/2016 Centralised - 2-Monthly update EMEA/H/C/3768/II/10 (2016)629 of 28/01/2016
28/06/2016 Centralised - Variation EMEA/H/C/3768/X/13 (2016)4086 of 24/06/2016
15/09/2016 Centralised - Variation EMEA/H/C/3768/II/19
Updated with Decision(2017) 1407 of 23/02/2017
15/09/2016 Centralised - Variation EMEA/H/C/3768/II/20
Updated with Decision(2017) 1407 of 23/02/2017
13/01/2017 Centralised - Variation EMEA/H/C/3768/IB/23
Updated with Decision(2017)9001 of 18/12/2017
27/02/2017 Referral EMEA/H/C/3768/A-20 (2017) 1407 of 23/02/2017
20/12/2017 Centralised - Yearly update (2017)9001 of 18/12/2017
13/01/2018 Centralised - Variation EMEA/H/C/3768/IB/27