Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Gardasil 9   
Auth. number : EU/1/15/1007
Active substance : human papillomavirus 9-valent vaccine (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: J07BM03 - papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58)
(See WHO ATC Index)
Indication: Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
• Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types
• Genital warts (Condyloma acuminata) caused by specific HPV types.
The use of Gardasil 9 should be in accordance with official recommendations.
Marketing Authorisation Holder: MSD VACCINS
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
12/06/2015 Centralised - Authorisation EMEA/H/C/3852 (2015)4099 of 10/06/2015
21/12/2015 Centralised - Notification EMEA/H/C/3852/N/6
Updated with Decision(2016)2086 of 04/04/2016
14/01/2016 Referral EMEA/H/C/3852/A-20/3852/1 (2016)187 of 12/01/2016
1/04/2016 Centralised - Variation EMEA/H/C/3852/II/7
Updated with Decision(2017) 1608 of 03/03/2017
6/04/2016 Centralised - 2-Monthly update EMEA/H/C/3852/II/4 (2016)2086 of 4/04/2016
12/05/2016 Centralised - Variation EMEA/H/C/3852/II/10
Updated with Decision(2017) 1608 of 03/03/2017
21/12/2016 Centralised - Notification EMEA/H/C/3852/N/14
Updated with Decision(2017) 1608 of 03/03/2017
11/01/2017 Centralised - Variation EMEA/H/C/3852/IG/759
Updated with Decision(2017) 1608 of 03/03/2017
24/02/2017 Centralised - Variation EMEA/H/C/3852/IG/777
Updated with Decision(2018) 1135 of 19/02/2018
7/03/2017 Centralised - Yearly update (2017) 1608 of 3/03/2017
24/03/2017 Centralised - Notification EMEA/H/C/3852/N/18
Updated with Decision(2018) 1135 of 19/02/2018
27/11/2017 Centralised - Notification EMEA/H/C/3852/N/21
Updated with Decision(2018) 1135 of 19/02/2018
21/02/2018 Centralised - Yearly update (2018) 1135 of 19/02/2018
26/07/2018 Centralised - Variation EMEA/H/C/3852/II/24/G
17/01/2019 Centralised - Variation EMEA/H/C/3852/II/28