Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Incivo   
Auth. number : EU/1/11/720
INN : telaprevir
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: J05AE11 - Telaprevir
(See WHO ATC Index)
Indication: INCIVO, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):- who are treatmentnaïve;- who have previously been treated with interferon alfa (pegylated or nonpegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  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
21/09/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2313 (2011)6650 of 19/09/2011
22/09/2011 Centralised - Authorisation EMEA/H/C/2313 (2011)6649 of 19/09/2011
15/10/2011 Centralised - Variation EMEA/H/C/2313/IB/1
Updated with Decision(2012)1906 of 19/03/2012
15/10/2011 Centralised - Notification EMEA/H/C/2313/N/2
Updated with Decision(2012)1906 of 19/03/2012
21/03/2012 Centralised - Variation EMEA/H/C/2313/II/3, 4 (2012)1906 of 19/03/2012
25/05/2012 Corrigendum (2012)3455 of 22/05/2012
29/10/2012 Centralised - Variation EMEA/H/C/2313/II/6 (2012)7720 of 25/10/2012
22/11/2012 Centralised - Variation EMEA/H/C/2313/II/10 (2012)8586 of 19/11/2012
21/02/2013 Centralised - Variation EMEA/H/C/2313/II/9
Updated with Decision(2013)2400 of 22/04/2013
24/04/2013 Centralised - 2-Monthly update EMEA/H/C/2313/II/13 (2013)2400 of 22/04/2013
25/04/2013 Centralised - Variation EMEA/H/C/2313/II/8/G
Updated with Decision(2013)3219 of 27/05/2013
29/05/2013 Centralised - 2-Monthly update EMEA/H/C/2313/II/14 (2013)3219 of 27/05/2013
02/08/2013 Centralised - Notification EMEA/H/C/2313/N/15
Updated with Decision(2013)7500 of 31/10/2013
04/11/2013 Centralised - 2-Monthly update EMEA/H/C/2313/IB/20 (2013)7500 of 31/10/2013
18/12/2013 Centralised - Variation EMEA/H/C/2313/II/19
Updated with Decision(2014)4263 of 19/06/2014
20/12/2013 Centralised - Modification EMEA/H/C/2313/PSUV/21 (2013)9713 of 18/12/2013
20/03/2014 Centralised - Variation EMEA/H/C/2313/II/22
Updated with Decision(2014)4263 of 19/06/2014
23/06/2014 Centralised - Modification EMEA/H/C/2313/PSUV/24 (2014)4263 of 19/06/2014
24/07/2014 Centralised - Variation EMEA/H/C/2313/II/26/G
Updated with Decision(2014)10108 of 16/12/2014
18/12/2014 Centralised - Modification EMEA/H/C/2313/PSUV/28 (2014)10108 of 16/12/2014