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Patent details

2025C531 Product name: niraparib of een farmaceutisch aanvaardbaar zout daarvan in het bijzonder niraparib-tosylaat in het bijzonder niraparib-tosylaatmonohydraat, optioneel in combinatie met abirateron in het bijzonder abirateronacetaat

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Basic information

Application number:
2025C/531
Type:
Certificate
SPC type:
Medical
Basic patent number:
177542263
Status:
Open & Published
Publication number:
2025C531
1rst applicant's nationality:
Procedural language:
Dutch

Marketing authorization

Marketing authorization number:
EU/1/23/1722
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
20/04/2023
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
22/07/2025
First marketing authorization date:
20/04/2023
Grant date:
Activation date:
BE Publication date:
25/07/2025
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
20/04/2038
SPC/SPC Extension Expiration (if granted and all annual fees paid):
Rejection date:
Withdrawal date:

Applicant

Name:
Janssen Pharmaceutica, N.V.
Legal Form:
NV
From:
25/07/2025
Address:
Turnhoutseweg 30, 2340 Beerse, Belgium (BE)
To:

Agent

Name:
GEVERS PATENTS
Legal Form:
From:
23/07/2025
Address:
De Kleetlaan 7A, 1831, DIEGEM, Belgium (BE)
To:

Publication

Bulletin

Bulletin heading:
SPC
Journal edition number:
2025/14
Publication date:
04/09/2025
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates
Filing date Document type Publication Type Document Description Number of pages File Type
22/07/2025 Abstract Product Characteristics Abstract of the characteristics of the product 62 PDF /6/2/3/1/6/0722561326/docs/2025c531_0_abstractproductcharacteristics_20250723_084528431.pdf
22/07/2025 General Document Other 1 PDF /6/2/3/1/6/0722561326/docs/2025c531_1_generaldocument_20250723_084528232.pdf
22/07/2025 MA Official Publication Official Publication of 1st Marketing Authorization 7 PDF /6/2/3/1/6/0722561326/docs/2025c531_2_maofficialpublication_20250723_084528726.pdf
22/07/2025 Marketing Authorization 1st Marketing Authorization (EU) 3 PDF /6/2/3/1/6/0722561326/docs/2025c531_3_marketingauthorization_20250723_084529010.pdf
22/07/2025 General Document Other 53 PDF /6/2/3/1/6/0722561326/docs/2025c531_4_generaldocument_20250723_084527998.pdf
22/07/2025 General Document Other 44 PDF /6/2/3/1/6/0722561326/docs/2025c531_5_generaldocument_20250723_084528097.pdf
22/07/2025 General Document Other 2 PDF /6/2/3/1/6/0722561326/docs/2025c531_6_generaldocument_20250723_084527911.pdf
22/07/2025 Application Form 4 PDF /6/2/3/1/6/0722561326/docs/2025c531_7_applicationform_20250723_084529338.pdf
25/07/2025 Publication I1 1 PDF /6/2/3/1/6/0722561326/docs/2025c531_8_i1document_20250725_115136649.pdf
25/07/2025 Outgoing Correspondence 2 PDF /6/2/3/1/6/0722561326/docs/2025c531_9_outgoingcorrespondence_20250730_100845925.pdf