Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zostavax   
Auth. number : EU/1/06/341
Active substance : shingles (herpes zoster) vaccine (live)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BK - Varicella zoster vaccines
Chemical substance: J07BK02 - Zoster, live attenuated
(See WHO ATC Index)
Indication: ZOSTAVAX is indicated for prevention of herpes zoster (“zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
ZOSTAVAX is indicated for immunization of individuals 50 years of age or older.
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
23/05/2006 Centralised - Authorisation EMEA/H/C/674 (2006)2115 of 19/05/2006
22/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/1
09/01/2007 Centralised - Variation EMEA/H/C/674/II/2, 4 (2007)19 of 03/01/2007
22/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/5
26/07/2007 Centralised - Variation EMEA/H/C/674/II/3 (2007)3643 of 24/07/2007
25/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/6
23/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/8
30/07/2008 Centralised - Variation EMEA/H/C/674/II/11 (2008)4108 of 28/07/2008
31/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/12
03/09/2008 Centralised - Variation EMEA/H/C/674/II/13 (2008)4825 of 01/09/2008
28/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/10
28/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/9
01/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/14
28/01/2009 Centralised - Variation EMEA/H/C/674/II/15 (2009)560 of 26/01/2009
02/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IB/16
01/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/20
29/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IB/21
03/06/2009 Centralised - Variation EMEA/H/C/674/II/17 (2009)4348 of 29/05/2009
09/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/22
30/06/2009 Centralised - Variation EMEA/H/C/674/IA/23
Updated with Decision(2009)8500 of 28/10/2009
08/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/24
01/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/25
30/10/2009 Centralised - Variation EMEA/H/C/674/II/26 (2009)8500 of 28/10/2009
22/01/2010 Centralised - Variation EMEA/H/C/674/II/27 (2010)368 of 20/01/2010
03/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/28
26/04/2010 Centralised - Variation EMEA/H/C/674/IA/29/G
Updated with Decision(2010)6021 of 26/08/2010
10/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IA/30
10/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/WS/18
31/08/2010 Centralised - Variation (2010)6021 of 26/08/2010
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/II/31
04/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/WS/17
22/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IB/33
27/10/2010 Centralised - Variation EMEA/H/C/674/WS/44 (2010)7552 of 25/10/2010
22/12/2010 Centralised - Variation EMEA/H/C/674/II/32 (2010)9605 of 20/12/2010
01/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/IB/35
28/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/674/WS/99/G
30/03/2011 Centralised - Renewal EMEA/H/C/674/R/34 (2011)2090 of 24/03/2011
24/01/2012 Centralised - Variation EMEA/H/C/674/II/37 (2012)417 of 20/01/2012
24/02/2012 Centralised - Variation EMEA/H/C/674/II/45 (2012)1277 of 21/02/2012
23/03/2012 Centralised - Variation EMEA/H/C/674/II/46 (2012)2023 of 21/03/2012
27/08/2012 Centralised - Variation EMEA/H/C/674/II/55 (2012)5999 of 23/08/2012
15/02/2013 Referral EMEA/H/C/674/A-20/52 (2013)934 of 13/02/2013
18/12/2013 Centralised - Variation EMEA/H/C/674/II/65/G
Updated with Decision(2015)116 of 12/01/2015
06/05/2014 Centralised - Variation EMEA/H/C/674/IG/435
Updated with Decision(2015)116 of 12/01/2015
25/09/2014 Centralised - Variation EMEA/H/C/674/II/73
Updated with Decision(2015)116 of 12/01/2015
20/11/2014 Centralised - Variation EMEA/H/C/674/II/77
Updated with Decision(2015)116 of 12/01/2015
14/01/2015 Centralised - Yearly update (2015)116 of 12/01/2015
23/04/2015 Centralised - Variation EMEA/H/C/674/II/90
Updated with Decision(2015)9748 of 18/12/2015
01/06/2015 Centralised - Notification EMEA/H/C/674/N/93
Updated with Decision(2015)9748 of 18/12/2015
22/12/2015 Centralised - Variation EMEA/H/C/674/X/85 (2015)9748 of 18/12/2015
15/02/2016 Centralised - Renewal EMEA/H/C/674/R/96 (2016)932 of 11/02/2016