Patent details

92898 Product Name: Gardasil -9 / Vaccination contre les stéréotypes 16,18 et 31Nom du produit : HPV L1 VLPs 16+18+31

Basic Information

Publication number:
92898
Type:
SPC
SPC Type:
Medical
Basic Patent Number:
EP057579534
Legal Status:
Active
Application number:
92898
First applicant's nationality:
Procedural language:
French

Paediatric Extension

SPC Extension Filing Date:
15/11/2022
SPC Extension Agent Name:
KIRKPATRICK
SPC Extension Status:
Granted
SPC Extension Grant Date:
22/10/2024
SPC Extension Rejection Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/15/1007 Gardasil-9
Marketing Authorization Type:
Marketing Authorization Date:
12/06/2015
Marketing Authorization Status:
Accepted
Marketing Authorization Country:

Dates

Filing date:
08/12/2015
First Marketing Authorization date:
12/06/2015
Grant date:
08/03/2016
Activation date:
14/06/2025
Publication date:
08/03/2016
Lapsed date:
Expiration date:
Renunciation date:
Revocation date:
Annulment date:
Basic SPC Expiration:
12/06/2030
SPC Extension Expiration:
12/12/2030
Rejection date:
Withdrawal date:

Owner

From:
08/12/2015
 
 

Name:
GlaxoSmithKline Biologicals SA
Address:
Rue de l'Institut 89, 1330 Rixensart, Belgium (BE)

Agent

Name:
KIRKPATRICK
From:
08/12/2015
Address:
AVENUE WOLFERS 32, 1310, LA HULPE, Belgium (BE)
To:

Inventor

1

Name:
WETTENDORFF Martine, Anne, Cécile
Address:
Belgium (BE)

2

Name:
STEPHEN Robert John GlaxoSmithKline
Address:
United Kingdom (GB)

3

Name:
MARTIN Marie-Therese
Address:
Belgium (BE)

4

Name:
DEBRUS Serge GlaxoSmithKline Biologicals S.A.
Address:
Belgium (BE)

5

Name:
STEPHENNE Jean GlaxoSmithKline Biologicals S.A.
Address:
Belgium (BE)

Publication

Bulletin

1

Bulletin Heading:
SPCX1
Bulletin edition number:
2022/13
Publication date:
01/12/2022
Description:
Section G : Applications for extensions for pediatric use – I1E publication

2

Bulletin Heading:
SPCX2
Bulletin edition number:
2024/13
Publication date:
05/11/2024
Description:
Section H : Granted extensions for pediatric use of supplementary protection certificates – I2E publication

3

Bulletin Heading:
SPC3
Bulletin edition number:
2025/08
Publication date:
03/07/2025
Description:
Section E : Supplementary Protection certificates entered into force – IA publication

Annual Fees

Annual Fee Due Date:
30/06/2026
Annual Fee Number:
22
Annual Fee Amount:
420 Euro
Expected Payer:
Last Annual Fee Payment Date:
19/03/2025
Last Annual Fee Paid Number:
21
Last Annual Fee Paid Amount:
410 Euro
Payer:
MASTER DATA CENTER INC (ex Clarivate Analytics)
Filing date Document type Number of pages
15/11/2022 Outgoing Correspondence 1
15/11/2022 Application Form 5
15/11/2022 Paediatric investigation plan 2
15/11/2022 MA publication 2
15/11/2022 General Document 2
15/11/2022 Marketing authorization 4
04/11/2024 Outgoing Correspondence 1
21/10/2024 Outgoing Correspondence 1
22/10/2024 Summary of the product caracteristics 59
15/11/2022 Publication 1
22/10/2024 Publication 1
22/10/2024 Certificate 1
15/11/2022 FNET_DC_FRONTPAGE 1