Patent details
300991
Product Name:
golimumab
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Basic Information
Publication number:
300991
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP3118318
Status:
Refused Art. 10 of the EC Regulations
Application number:
300991
Procedural language:
Dutch
First Applicant Residence Country:
United States of America (US)
Marketing Authorization
Marketing Authorization Number:
(2016)4081
Marketing Authorization Type:
EEA
Marketing Authorization Date:
28/06/2016
Marketing Authorization Country:
European Union (EU)
Dates
Filing date:
23/05/2019
First Marketing Authorization date:
28/06/2016
Grant date:
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
27/05/2019
SPC/SPC Extension Expiration Date:
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:
05/02/2021
Applicant/holder
From:
23/05/2019
Name:
Janssen Biotech, Inc.
Address:
800/850 Ridgeview Drive, HORSHAM, PA 19044, United States of America (US)
Agent
Name:
ir. H.A. Witmans c.s.
From:
23/05/2019
Address:
V.O.
Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:
Publication
Bulletin
1
Bulletin Heading:
VRV
Journal edition number:
06/21
Publication date:
10/02/2021
Description:
Lapse or annulment
2
Bulletin Heading:
SPC
Journal edition number:
22/19
Publication date:
29/05/2019
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
05/02/2021
Outgoing Correspondence
Decision refusal
3
PDF
/0/0/5/5/1/0800415500/docs/300991_6_393294l527a.pdf
07/10/2020
SPC Documents
Annex SPC
4
PDF
/0/0/5/5/1/0800415500/docs/300991_0_supplprotectioncertificate20201007105925755.pdf
07/10/2020
Outgoing Correspondence
Letter to applicant
1
PDF
/0/0/5/5/1/0800415500/docs/300991_4_370822l173.pdf
05/10/2020
SPC Documents
Annex SPC
11
PDF
/0/0/5/5/1/0800415500/docs/300991_2_supplprotectioncertificate20201006093258681.pdf
05/10/2020
SPC Documents
Accompanying letter SPC
3
PDF
/0/0/5/5/1/0800415500/docs/300991_5_supplprotectioncertificate20201006093258608.pdf
29/07/2020
Outgoing Correspondence
Letter to applicant
3
PDF
/0/0/5/5/1/0800415500/docs/300991_1_357094l173.pdf
28/05/2019
Outgoing Correspondence
Confirmation receipt request
1
PDF
/0/0/5/5/1/0800415500/docs/300991_10_276581l174.pdf
23/05/2019
SPC Documents
Annex SPC
111
PDF
/0/0/5/5/1/0800415500/docs/300991_3_supplprotectioncertificate20190527020304725.pdf
23/05/2019
Application Form
First filed application form
3
PDF
/0/0/5/5/1/0800415500/docs/300991_7_applicationform20190527020304278.pdf
23/05/2019
SPC Documents
Accompanying letter SPC
2
PDF
/0/0/5/5/1/0800415500/docs/300991_8_supplprotectioncertificate20190527020304433.pdf
23/05/2019
SPC Documents
Summary of the characteristics of the product
113
PDF
/0/0/5/5/1/0800415500/docs/300991_9_supplprotectioncertificate20190527020304573.pdf
23/05/2019
SPC Documents
Annex SPC
3
PDF
/0/0/5/5/1/0800415500/docs/300991_11_supplprotectioncertificate20190527020304652.pdf
23/05/2019
SPC Documents
Marketing Authorization SPC
3
PDF
/0/0/5/5/1/0800415500/docs/300991_12_supplprotectioncertificate20190527020304502.pdf