Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Celsentri   
Auth. number : EU/1/07/418
Active substance : maraviroc
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: J05AX09 - Maraviroc
(See WHO ATC Index)
Indication: In combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable.
Marketing Authorisation Holder: ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, 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
20/09/2007 Centralised - Authorisation EMEA/H/C/811 (2007)4383 of 18/09/2007
08/11/2007 Corrigendum EMEA/H/C/811 (2007)4383 cor of 06/11/2007
17/03/2008 Centralised - Notification EMEA/H/C/811/N/1
Updated with Decision(2008)6490 of 28/10/2008
30/10/2008 Centralised - Variation EMEA/H/C/811/II/3 (2008)6490 of 28/10/2008
04/11/2008 Centralised - Variation EMEA/H/C/811/II/2, 4 (2008)6657 of 31/10/2008
09/07/2009 Centralised - Variation EMEA/H/C/811/II/8 (2009)5600 of 07/07/2009
11/08/2009 Centralised - Variation EMEA/H/C/811/II/5, 7 (2009)6355 of 07/08/2009
09/11/2009 Centralised - Variation EMEA/H/C/811/II/6 (2009)8714 of 05/11/2009
11/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/811/IB/12
16/03/2010 Centralised - Variation EMEA/H/C/811/IA/13
Updated with Decision(2010)3076 of 05/05/2010
29/03/2010 Centralised - Variation EMEA/H/C/811/II/11 (2010)2177 of 26/03/2010
29/03/2010 Centralised - Variation EMEA/H/C/811/II/9 (2010)2178 of 26/03/2010
07/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/811/T/14 (2010)3076 of 05/05/2010
04/06/2010 Centralised - Variation EMEA/H/C/811/II/10 (2010)3671 of 02/06/2010
24/06/2010 Centralised - Variation EMEA/H/C/811/IA/16
Updated with Decision(2010)9642 of 20/12/2010
18/11/2010 Centralised - Variation EMEA/H/C/811/IA/17
Updated with Decision(2010)9642 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/811/II/15 (2010)9642 of 20/12/2010
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/811/IA/19
29/03/2011 Centralised - Variation EMEA/H/C/811/IA/20
Updated with Decision(2011)7392 of 12/10/2011
13/10/2011 Centralised - Variation (2011)7392 of 12/10/2011
23/11/2011 Centralised - Variation EMEA/H/C/811/II/22 (2011)8651 of 21/11/2011
19/03/2012 Centralised - Notification EMEA/H/C/811/N/24
Updated with Decision(2012)5290 of 20/07/2012
25/07/2012 Centralised - Renewal EMEA/H/C/811/R/25 (2012)5290 of 20/07/2012
21/02/2013 Centralised - Variation EMEA/H/C/811/II/26, 27, 29
Updated with Decision(2014)1301 of 21/02/2014
25/04/2013 Centralised - Variation EMEA/H/C/811/II/28
Updated with Decision(2014)1301 of 21/02/2014
25/05/2013 Centralised - Variation EMEA/H/C/811/IB/30
Updated with Decision(2014)1301 of 21/02/2014
19/09/2013 Centralised - Variation EMEA/H/C/811/II/32, 35
Updated with Decision(2014)1301 of 21/02/2014
24/10/2013 Centralised - Variation EMEA/H/C/811/II/33, 36
Updated with Decision(2014)1301 of 21/02/2014
18/12/2013 Centralised - Variation EMEA/H/C/811/II/34
Updated with Decision(2014)1301 of 21/02/2014
25/02/2014 Centralised - Yearly update (2014)1301 of 21/02/2014
25/04/2014 Centralised - Variation EMEA/H/C/811/WS/544
Updated with Decision(2015)3213 of 06/05/2015
26/03/2015 Centralised - Variation EMEA/H/C/811/II/41
Updated with Decision(2016)1604 of 10/03/2016
23/04/2015 Centralised - Variation EMEA/H/C/811/WS/645
Updated with Decision(2016)1604 of 10/03/2016
08/05/2015 Centralised - Yearly update (2015)3213 of 06/05/2015
27/11/2015 Centralised - Notification EMEA/H/C/811/N/44
Updated with Decision(2016)1604 of 10/03/2016
14/03/2016 Centralised - Yearly update (2016)1604 of 10/03/2016