Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Victrelis   
Auth. number : EU/1/11/704
INN : boceprevir
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: J05AE - Protease inhibitors
Chemical substance: J05AE12 - Boceprevir
(See WHO ATC Index)
Indication: Treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
19/07/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2332 (2011) 5298 of 18/07/2011
20/07/2011 Centralised - Authorisation EMEA/H/C/2332 (2011) 5297 of 18/07/2011
26/08/2011 Centralised - Notification EMEA/H/C/2332/N/1
Updated with Decision(2012)2021 of 21/03/2012
10/02/2012 Centralised - Variation EMEA/H/C/2332/IAin/3/G
Updated with Decision(2012)2021 of 21/03/2012
23/03/2012 Centralised - Variation EMEA/H/C/2332/II/4 (2012)2021 of 21/03/2012
03/08/2012 Centralised - Variation EMEA/H/C/2332/II/5 (2012)5617 of 31/07/2012
15/11/2012 Centralised - Variation EMEA/H/C/2332/II/7
Updated with Decision(2013)5756 of 03/09/2013
17/01/2013 Centralised - Variation EMEA/H/C/2332/II/6
Updated with Decision(2013)5756 of 03/09/2013
21/02/2013 Centralised - Variation EMEA/H/C/2332/II/8
Updated with Decision(2013)5756 of 03/09/2013
21/03/2013 Centralised - Variation EMEA/H/C/2332/II/13
Updated with Decision(2013)5756 of 03/09/2013
21/03/2013 Centralised - Variation EMEA/H/C/2332/II/12
Updated with Decision(2013)5756 of 03/09/2013
21/03/2013 Centralised - Variation EMEA/H/C/2332/II/11
Updated with Decision(2013)5756 of 03/09/2013
27/06/2013 Centralised - Variation EMEA/H/C/2332/II/15
Updated with Decision(2013)5756 of 03/09/2013
25/07/2013 Centralised - Variation EMEA/H/C/2332/II/17
Updated with Decision(2014)1136 of 17/02/2014
05/09/2013 Centralised - Modification EMEA/H/C/2332/PSUV/20 (2013)5756 of 03/09/2013
19/09/2013 Centralised - Variation EMEA/H/C/2332/II/21
Updated with Decision(2014)1136 of 17/02/2014
19/09/2013 Centralised - Variation EMEA/H/C/2332/II/19
Updated with Decision(2014)1136 of 17/02/2014
24/10/2013 Centralised - Variation EMEA/H/C/2332/II/14
Updated with Decision(2014)1136 of 17/02/2014
21/11/2013 Centralised - Variation EMEA/H/C/2332/II/22
Updated with Decision(2014)1136 of 17/02/2014
24/01/2014 Centralised - 2-Monthly update EMEA/H/C/2332/IB/26 (2014)417 of 22/01/2014
19/02/2014 Centralised - Modification EMEA/H/C/2332/PSUV/24 (2014)1136 of 17/02/2014
25/03/2014 Centralised - 2-Monthly update EMEA/H/C/2332/II/27 (2014)2064 of 21/03/2014
26/08/2014 Centralised - Modification EMEA/H/C/2332/PSUV/28 (2014)6086 of 22/08/2014