Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zepatier   
Auth. number : EU/1/16/1119
Active substance : elbasvir / grazoprevir
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: J05AP - Antivirals for treatment of HCV infections
Chemical substance: J05AP54 - elbasvir and grazoprevir
(See WHO ATC Index)
Indication: ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/07/2016 Centralised - Authorisation EMEA/H/C/4126 (2016)4920 of 22/07/2016
16/12/2016 Centralised - Variation EMEA/H/C/4126/IAIN/4
Updated with Decision(2017)8251 of 30/11/2017
23/03/2017 Centralised - Variation EMEA/H/C/4126/II/6
Updated with Decision(2017)8251 of 30/11/2017
6/04/2017 Centralised - Variation EMEA/H/C/4126/II/5
Updated with Decision(2017)8251 of 30/11/2017
5/07/2017 Centralised - Variation EMEA/H/C/4126/IB/10
Updated with Decision(2017)8251 of 30/11/2017
4/12/2017 Centralised - Yearly update (2017)8251 of 30/11/2017
19/06/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4126/T/15 (2018)3917 of 15/06/2018
17/01/2019 Centralised - Variation EMEA/H/C/4126/IAIN/18G