Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Isentress   
Auth. number : EU/1/07/436
INN : raltegravir
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: J05AX08 - Raltegravir
(See WHO ATC Index)
Indication: ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults, adolescents, and children from the age of 2 years.
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 continues to be 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
02/01/2008 Centralised - Authorisation EMEA/H/C/860 (2007)6801 of 20/12/2007
08/07/2008 Centralised - Variation EMEA/H/C/860/IB/2, 3, 4
27/08/2008 Centralised - Variation EMEA/H/C/860/IB/6
01/09/2008 Centralised - Variation EMEA/H/C/860/II/7 (2008)4746 of 28/08/2008
21/11/2008 Centralised - Annual renewal EMEA/H/C/860/R/8 (2008)7394 of 19/11/2008
09/01/2009 Centralised - Variation EMEA/H/C/860/II/1 (2009)52 of 07/01/2009
23/04/2009 Centralised - Variation EMEA/H/C/860/II/11 (2009)3130 of 21/04/2009
01/06/2009 Centralised - Variation EMEA/H/C/860/II/9 (2009)4322 of 28/05/2009
11/06/2009 Centralised - Variation EMEA/H/C/860/II/12
16/07/2009 Centralised - Authorisation (orphan status) EMEA/H/C/860/SW/13 (2009)5761 of 14/07/2009
21/07/2009 Centralised - Variation EMEA/H/C/860/II/14 (2009)5828 of 16/07/2009
15/09/2009 Centralised - Variation EMEA/H/C/860/II/10 (2009)6966 of 09/09/2009
30/03/2010 Centralised - Variation EMEA/H/C/860/II/17 (2010)2149 of 26/03/2010
30/04/2010 Centralised - Variation EMEA/H/C/860/II/16
22/06/2010 Centralised - Variation EMEA/H/C/860/IA/20
06/09/2010 Centralised - Variation EMEA/H/C/860/II/18, 19 (2010)6103 of 31/08/2010
18/11/2010 Centralised - Variation EMEA/H/C/860/IA/27/G
Updated with Decision(2011)455 of 24/01/2011
03/01/2011 Centralised - Variation EMEA/H/C/860/IA/21
27/01/2011 Centralised - Variation (2011)455 of 24/01/2011
20/08/2011 Centralised - Variation EMEA/H/C/860/N/23
Updated with Decision(2011)8650 of 21/11/2011
23/11/2011 Centralised - Variation EMEA/H/C/860/II/22 (2011)8650 of 21/11/2011
21/02/2012 Centralised - Variation EMEA/H/C/860/II/25 (2012)1175 of 17/02/2012
21/03/2012 Centralised - Variation EMEA/H/C/860/II/28 (2012)1924 of 19/03/2012
03/08/2012 Centralised - Variation EMEA/H/C/860/II/32 (2012)5616 of 31/07/2012
30/10/2012 Centralised - Variation EMEA/H/C/860/II/33 (2012)7760 of 25/10/2012
17/01/2013 Centralised - Variation EMEA/H/C/860/II/35, 37
Updated with Decision(2013)9657 of 17/12/2013
27/02/2013 Centralised - Variation EMEA/H/C/860/II/36, EMEA/H/C/860/X/24 (2013)1186 of 25/02/2013
25/04/2013 Centralised - Variation EMEA/H/C/860/II/40
Updated with Decision(2013)9657 of 17/12/2013
24/05/2013 Centralised - Variation EMEA/H/C/860/IB/41
Updated with Decision(2013)9657 of 17/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/860/II/42
Updated with Decision(2013)9657 of 17/12/2013
19/12/2013 Centralised - Variation (2013)9657 of 17/12/2013
20/02/2014 Centralised - Variation EMEA/H/C/860/II/47