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Patent details

2015C080 Product name: Gehumaniseerd monoclonaal anti-programmed cell death-1 (PD-1) antilichaam met lichte keten CDRs SEQ ID NOs:15, 16 en 17 en zware keten CDRs SEQ ID NOs:18, 19 en 20, in het bijzonder pembrolizumab

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Basic information

Application number:
2015C/080
Type:
Certificate
SPC type:
Medical
Basic patent number:
087684858
Status:
Open
Publication number:
2015C080
1rst applicant's nationality:
Procedural language:
Dutch

Paediatric extension

SPC Extension filing date:
18/11/2021
SPC Extension agent/owner name:
NLO
SPC Extension status:
Open & Published
SPC Extension grant date:
SPC Extension Rejection Date:

Marketing authorization

Marketing authorization number:
EU/1/15/1024/001
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
21/07/2015
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
23/12/2015
First marketing authorization date:
21/07/2015
Grant date:
Activation date:
BE Publication date:
25/01/2016
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
21/07/2030
SPC/SPC Extension Expiration (if granted and all annual fees paid):
21/01/2031
Rejection date:
Withdrawal date:

Applicant

Name:
Merck Sharp & Dohme B.V.
Legal Form:
From:
25/01/2016
Address:
Waarderweg 39, 2031 BN, Haarlem, Netherlands (NL)
To:

Agent

1

Name:
MANNAERTS Jaap
Legal Form:
From:
16/12/2024
Address:
New Babylon City Offices Anna van Buerenplein 21A, 2595 DA DEN HAAG, Netherlands (NL)
To:

2

Name:
MANNAERTS Jaap
Legal Form:
From:
26/03/2019
Address:
Technologiepark 122, 9052, ZWIJNAARDE - GENT, Belgium (BE)
To:
16/12/2024

3

Name:
MANNAERTS Jaap
Legal Form:
From:
25/01/2016
Address:
Technologiepark 122, 9052, ZWIJNAARDE - GENT, Belgium (BE)
To:
26/03/2019

Publication

Bulletin

Bulletin heading:
SPC
Journal edition number:
2021/22
Publication date:
10/01/2022
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
30/06/2028
Annual fee number:
21
Annual fee amount:
650 Euro
Expected payer:
Last annual fee payment date:
Last annual fee paid number:
Payer:
Filing date Document type Publication Type Document Description Number of pages File Type
25/01/2016 Publication I1 1 PDF /9/8/4/5/8/0721485489/docs/2015c080_0_i1document_20160125_153432821.pdf
25/01/2016 General Document Other 2 PDF /9/8/4/5/8/0721485489/docs/2015c080_1_generaldocument_20160128_114518209.pdf
23/12/2015 General Document Other 40 PDF /9/8/4/5/8/0721485489/docs/2015c080_2_generaldocument_20160122_111626211.pdf
25/01/2016 Front Page 1 PDF /9/8/4/5/8/0721485489/docs/2015c080_3_i1frontpage_20160125_153428685.pdf
18/11/2021 General Document Other 53 PDF /9/8/4/5/8/0721485489/docs/2015c080_4_generaldocument_20211119_084812748.pdf
22/11/2021 Publication I1E 1 PDF /9/8/4/5/8/0721485489/docs/2015c080_5_i1edocument_20211122_143145537.pdf
23/06/2016 General Document Other 3 PDF /9/8/4/5/8/0721485489/docs/2015c080_6_generaldocument_20160705_103106065.pdf
18/11/2021 Application Form 3 PDF /9/8/4/5/8/0721485489/docs/2015c080_7_applicationform_20211119_084814206.pdf
23/12/2015 Application Form 3 PDF /9/8/4/5/8/0721485489/docs/2015c080_8_applicationform_20160122_111625977.pdf
18/11/2021 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 1 PDF /9/8/4/5/8/0721485489/docs/2015c080_9_paediatricinvestigationplan_20211119_084813450.pdf
22/11/2021 Outgoing Correspondence 2 PDF /9/8/4/5/8/0721485489/docs/2015c080_10_outgoingcorrespondence_20211129_023327081.pdf
26/03/2019 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /9/8/4/5/8/0721485489/docs/2015c080_11_rfc_20190326_035611022.pdf
23/12/2015 General Document Other 36 PDF /9/8/4/5/8/0721485489/docs/2015c080_12_generaldocument_20160122_111626130.pdf
18/11/2021 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 3 PDF /9/8/4/5/8/0721485489/docs/2015c080_13_marketingauthorization_20211119_084813184.pdf
23/12/2015 General Document Other 1 PDF /9/8/4/5/8/0721485489/docs/2015c080_14_generaldocument_20160122_111626053.pdf
27/11/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /9/8/4/5/8/0721485489/docs/2015c080_15_206455_pie.rfc.per.notif.pdf
27/11/2024 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /9/8/4/5/8/0721485489/docs/2015c080_16_rfc_20241127_012947133.pdf
16/12/2024 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /9/8/4/5/8/0721485489/docs/2015c080_17_rfc_20241217_095655680.pdf
18/12/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /9/8/4/5/8/0721485489/docs/2015c080_18_207803_pie.rfc.per.notif.pdf