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