Patent details

301151 Product Name: Neisseria meningitidis-groep A polysaccharide, Neisseria meningitidis-groep C polysaccharide, Neisseria meningitidis-groep W-135 polysaccharide, Neisseria meningitidis-groep Y polysaccharide, geconjugeerd aan tetanustoxoïddragereiwit, of een biosimilar product in de zin van Artikel 10(4) van richtlijn 2001/83/EG

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Basic Information

Publication number:
301151
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP3009146
Status:
Application Pending
Application number:
301151
Procedural language:
Dutch
First Applicant Residence Country:
Ireland (IE)

Paediatric Extension

SPC Extension Filing Date:
12/06/2023
SPC Extension Agent/Owner Name:
ir. M.F.J.M. Ketelaars c.s. , Pfizer Ireland Pharmaceuticals
SPC Extension Status:
Application Pending
SPC Extension Grant Date:
SPC Extension Request Refusal Date:
SPC Extension Revocation Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/12/767
Marketing Authorization Type:
EEA
Marketing Authorization Date:
25/04/2012
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
07/12/2021
First Marketing Authorization date:
25/04/2012
Grant date:
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
07/12/2021
SPC/SPC Extension Expiration Date:
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
07/12/2021
 
 

 

Name:
Pfizer Ireland Pharmaceuticals
Address:
Operations Support Group, Ringaskiddy Cork, Ireland (IE)

Agent

Name:
ir. M.F.J.M. Ketelaars c.s.
From:
07/12/2021
Address:
NLO Postbus 29720, 2502 LS, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
24/23
Publication date:
14/06/2023
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
49/21
Publication date:
08/12/2021
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Filing date Document type Document Description Number of pages File Type
12/06/2023 Application Form First filed application form 3 PDF /0/5/1/0/5/0800750150/docs/301151_7_applicationform20230612092647281.pdf
12/06/2023 SPC Documents Marketing Authorization SPC 3 PDF /0/5/1/0/5/0800750150/docs/301151_8_supplprotectioncertificate20230612092846069.pdf
12/06/2023 SPC Documents Annex SPC 1 PDF /0/5/1/0/5/0800750150/docs/301151_9_supplprotectioncertificate20230612094106105.pdf
12/06/2023 SPC Documents Summary of the characteristics of the product 29 PDF /0/5/1/0/5/0800750150/docs/301151_10_supplprotectioncertificate20230612092807900.pdf
12/06/2023 Outgoing Correspondence Confirmation receipt request for extension 2 PDF /0/5/1/0/5/0800750150/docs/301151_11_549712l505.pdf
07/12/2021 SPC Documents Marketing Authorization SPC 5 PDF /0/5/1/0/5/0800750150/docs/301151_0_supplprotectioncertificate20211207121022517.pdf
07/12/2021 SPC Documents Annex SPC 3 PDF /0/5/1/0/5/0800750150/docs/301151_1_supplprotectioncertificate20211207121408215.pdf
07/12/2021 SPC Documents Summary of the characteristics of the product 26 PDF /0/5/1/0/5/0800750150/docs/301151_2_supplprotectioncertificate20211207121408160.pdf
07/12/2021 Application Form First filed application form 2 PDF /0/5/1/0/5/0800750150/docs/301151_3_applicationform20211207120843313.pdf
07/12/2021 Outgoing Correspondence Confirmation receipt request 1 PDF /0/5/1/0/5/0800750150/docs/301151_4_450012l174.pdf
07/12/2021 SPC Documents Annex SPC 24 PDF /0/5/1/0/5/0800750150/docs/301151_5_supplprotectioncertificate20211207121408238.pdf
07/12/2021 SPC Documents Annex SPC 11 PDF /0/5/1/0/5/0800750150/docs/301151_6_supplprotectioncertificate20211207121442723.pdf