Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Silgard   
Auth. number : EU/1/06/358
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: Silgard 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 Silgard should be in accordance with official recommendations.
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
15/09/2006 Centralised - Authorisation EMEA/H/C/732 (2006)4283 of 20/09/2006
04/10/2006 Corrigendum EMEA/H/C/732
17/01/2007 Centralised - Variation EMEA/H/C/732/N/2
Updated with Decision(2007)2603 of 13/06/2007
29/03/2007 Centralised - Variation EMEA/H/C/732/II/1
06/06/2007 Centralised - Variation EMEA/H/C/732/II/4
15/06/2007 Centralised - Variation EMEA/H/C/732/II/3 (2007)2603 of 13/06/2007
27/07/2007 Centralised - Variation EMEA/H/C/732/II/5 (2007)3682 of 24/07/2007
30/08/2007 Centralised - Variation EMEA/H/C/732/IA/11
Updated with Decision(2008)1450 of 10/04/2008
30/08/2007 Centralised - Variation EMEA/H/C/732/IA/10
Updated with Decision(2008)1450 of 10/04/2008
30/08/2007 Centralised - Variation EMEA/H/C/732/IA/8
Updated with Decision(2008)1450 of 10/04/2008
30/08/2007 Centralised - Variation EMEA/H/C/732/IA/9
Updated with Decision(2008)1450 of 10/04/2008
27/09/2007 Centralised - Variation EMEA/H/C/732/II/7
03/10/2007 Centralised - Variation EMEA/H/C/732/IB/13
28/03/2008 Centralised - Variation EMEA/H/C/732/II/14
14/04/2008 Centralised - Variation (2008)1450 of 10/04/2008
11/06/2008 Centralised - Variation EMEA/H/C/732/II/15
14/07/2008 Centralised - Variation EMEA/H/C/732/II/12 (2008)3665 of 10/07/2008
04/09/2008 Centralised - Variation EMEA/H/C/732/II/6 (2008)4956 of 02/09/2008
04/11/2008 Centralised - Variation EMEA/H/C/732/II/16 (2008)6654 of 31/10/2008
04/02/2009 Centralised - Variation EMEA/H/C/732/II/17 (2009)752 of 02/02/2009
10/03/2009 Centralised - Variation EMEA/H/C/732/II/19 (2009)1706 of 06/03/2009
04/06/2009 Centralised - Variation EMEA/H/C/732/II/20 (2009)4402 of 02/06/2009
30/07/2009 Centralised - Variation EMEA/H/C/732/II/21, 22 (2009)6060 of 24/07/2009
07/09/2009 Centralised - Variation EMEA/H/C/732/II/18 (2009)6827 of 02/09/2009
17/03/2010 Centralised - Variation EMEA/H/C/732/IB/25
19/03/2010 Centralised - Variation EMEA/H/C/732/IA/26/G
Updated with Decision(2010)3081 of 05/05/2010
07/05/2010 Centralised - Variation EMEA/H/C/732/II/23 (2010)3081 of 05/05/2010
25/08/2010 Centralised - Variation EMEA/H/C/732/II/24 (2010)5922 of 23/08/2010
08/11/2010 Centralised - Variation EMEA/H/C/732/IG/27/G
Updated with Decision(2011)1606 of 04/03/2011
08/03/2011 Centralised - Variation (2011)1606 of 04/03/2011
25/07/2011 Centralised - Renewal EMEA/H/C/732/R/27 (2011)5393 of 20/07/2011
02/08/2011 Centralised - Variation EMEA/H/C/732/WS/29 (2011)5602 of 27/07/2011
26/08/2011 Corrigendum EMEA/H/C/697/N/2
15/11/2011 Centralised - Variation EMEA/H/C/732/WS/29 (2011)8237 of 10/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/732/II/WS/142 (2011)9947 of 19/12/2011
25/05/2012 Centralised - Variation EMEA/H/C/732/WS/241 (2012)3467 of 22/05/2012
04/12/2012 Centralised - Variation EMEA/H/C/732/WS/315 (2012)9093 of 30/11/2012
16/07/2013 Centralised - Variation EMEA/H/C/732/N/39
Updated with Decision(2014)2154 of 27/03/2014
31/03/2014 Centralised - Variation EMEA/H/C/732/WS/472 (2014)2154 of 27/03/2014
13/06/2014 Centralised - Variation EMEA/H/C/732/WS/523 (2014)3950 of 06/06/2014
26/06/2014 Centralised - Variation EMEA/H/C/732/WS/545