Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Gardasil   
Auth. number : EU/1/06/357
INN : Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BM - Papillomavirus vaccines
Chemical substance: J07BM01 - Papillomavirus (human types 6, 11, 16, 18) Papillomavirus (human types 16, 18)
(See WHO ATC Index)
Indication: Gardasil is a vaccine for use from the age of 9 years for the prevention of:
– premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types
– genital warts (condyloma acuminata) causally related to specific HPV types.
See sections 4.4 and 5.1 for important information on the data that support this indication.
The use of Gardasil should be in accordance with official recommendations.
Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69007 Lyon, France

  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
22/09/2006 Centralised - Authorisation EMEA/H/C/703 (2006)4281 of 20/09/2006
17/01/2007 Centralised - Notification EMEA/H/C/703/N/2
Updated with Decision(2007)2600 of 13/06/2007
30/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/II/1
06/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/II/4
15/06/2007 Centralised - Variation EMEA/H/C/703/II/3 (2007)2600 of 13/06/2007
27/07/2007 Centralised - Variation EMEA/H/C/703/II/5 (2007)3681 of 24/07/2007
22/08/2007 Centralised - Variation EMEA/H/C/703/IA/11
Updated with Decision(2008)1449 of 10/04/2008
22/08/2007 Centralised - Variation EMEA/H/C/703/IA/9
Updated with Decision(2008)1449 of 10/04/2008
22/08/2007 Centralised - Variation EMEA/H/C/703/IA/10
Updated with Decision(2008)1449 of 10/04/2008
22/08/2007 Centralised - Variation EMEA/H/C/703/IA/12
Updated with Decision(2008)1449 of 10/04/2008
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/II/7
03/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/IB/14
28/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/II/15
10/04/2008 Centralised - Notification EMEA/H/C/703/N/17
Updated with Decision(2008)3664 of 10/07/2008
15/04/2008 Centralised - Variation (2008)1449 of 10/04/2008
11/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/II/16
15/07/2008 Centralised - Variation EMEA/H/C/703/II/13 (2008)3664 of 10/07/2008
05/09/2008 Centralised - Variation EMEA/H/C/703/II/6 (2008)4955 of 02/09/2008
04/11/2008 Centralised - Variation EMEA/H/C/703/II/18 (2008)6653 of 31/10/2008
04/02/2009 Centralised - Variation EMEA/H/C/703/II/19 (2009)753 of 02/02/2009
06/03/2009 Centralised - Variation EMEA/H/C/703/II/21 (2009)1653 of 04/03/2009
02/06/2009 Centralised - Variation EMEA/H/C/703/II/22 (2009)4328 of 28/05/2009
30/07/2009 Centralised - Variation EMEA/H/C/703/II/23 (2009)6072 of 24/07/2009
02/09/2009 Centralised - Variation EMEA/H/C/703/II/20 (2009)6750 of 31/08/2009
21/01/2010 Centralised - Variation EMEA/H/C/703/II/24 (2010)341 of 19/01/2010
19/03/2010 Centralised - Variation EMEA/H/C/703/IA/28/G
Updated with Decision(2010)3217 of 12/05/2010
23/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/703/IB/27
18/05/2010 Centralised - Variation EMEA/H/C/703/II/25 (2010)3217 of 12/05/2010
20/08/2010 Centralised - Variation EMEA/H/C/703/II/26 (2010)5843 of 18/08/2010
29/07/2011 Centralised - Renewal EMEA/H/C/703/R/29 (2011)5586 of 27/07/2011
03/08/2011 Centralised - Variation EMEA/H/C/703/II/WS/29 (2011)5692 of 01/08/2011
18/11/2011 Centralised - Variation EMEA/H/C/703/II/WS/29 (2011)8513 of 16/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/703/II/WS/142 (2011)9947 of 19/12/2011
25/05/2012 Centralised - Variation EMEA/H/C/703/WS/241 (2012)3466 of 22/05/2012
04/12/2012 Centralised - Variation EMEA/H/C/703/WS/315 (2012)9095 of 30/11/2012
16/07/2013 Centralised - Notification EMEA/H/C/703/N/41
Updated with Decision(2014)2153 of 27/03/2014
31/03/2014 Centralised - 2-Monthly update EMEA/H/C/703/WS/472 (2014)2153 of 27/03/2014
06/05/2014 Centralised - Variation EMEA/H/C/703/IG/435
Updated with Decision(2014)3949 of 06/06/2014
12/06/2014 Centralised - 2-Monthly update EMEA/H/C/703/WS/523 (2014)3949 of 06/06/2014
26/06/2014 Centralised - Variation EMEA/H/C/703/WS/545