Patent details
300989
Product Name:
damoctocog alfa pegol
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Basic Information
Publication number:
300989
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP1824988
Status:
SPC granted but not yet in force
Application number:
300989
Procedural language:
Dutch
First Applicant Residence Country:
United States of America (US)
Paediatric Extension
SPC Extension Filing Date:
10/05/2019
SPC Extension Agent/Owner Name:
Bayer HealthCare LLC
, ir. H.A. Witmans c.s.
SPC Extension Status:
Extension Granted
SPC Extension Grant Date:
28/11/2019
SPC Extension Request Refusal Date:
SPC Extension Revocation Date:
Marketing Authorization
Marketing Authorization Number:
EU/1/18/1324
Marketing Authorization Type:
EEA
Marketing Authorization Date:
26/11/2018
Marketing Authorization Country:
European Union (EU)
Dates
Filing date:
10/05/2019
First Marketing Authorization date:
26/11/2018
Grant date:
28/11/2019
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
20/05/2019
SPC/SPC Extension Expiration Date:
13/05/2031
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:
Applicant/holder
From:
10/05/2019
Name:
Bayer HealthCare LLC
Address:
100 Bayer Boulevard, Whippany, NJ 07981, United States of America (US)
Agent
Name:
ir. H.A. Witmans c.s.
From:
10/05/2019
Address:
V.O.
Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:
Publication
Bulletin
1
Bulletin Heading:
SPC
Journal edition number:
49/19
Publication date:
04/12/2019
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
Bulletin Heading:
SPC
Journal edition number:
49/19
Publication date:
04/12/2019
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
Bulletin Heading:
SPC
Journal edition number:
21/19
Publication date:
22/05/2019
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
Bulletin Heading:
SPC
Journal edition number:
21/19
Publication date:
22/05/2019
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Annual Fee
Annual Fee(s) Due Date:
30/11/2025
Annual Fee Number:
21
Annual Fee Amount:
1600 Euro
Last Annual Payment Date:
Last Annual Fee Paid Number:
Payer:
Filing date
Document type
Document Description
Number of pages
File Type
28/11/2019
SPC Documents
Certificate SPC
1
PDF
/3/1/6/2/1/0800412613/docs/300989_4_supplprotectioncertificate20191129113918572.pdf
28/11/2019
Outgoing Correspondence
Decision grant
1
PDF
/3/1/6/2/1/0800412613/docs/300989_10_outgoingcorrespondence20191129113918484.pdf
20/05/2019
Outgoing Correspondence
Confirmation receipt request
1
PDF
/3/1/6/2/1/0800412613/docs/300989_6_275008l174.pdf
20/05/2019
Outgoing Correspondence
Confirmation receipt request for extension
1
PDF
/3/1/6/2/1/0800412613/docs/300989_13_275010l505.pdf
14/05/2019
SPC Documents
Annex SPC
3
PDF
/3/1/6/2/1/0800412613/docs/300989_0_supplprotectioncertificate20190520030541877.pdf
14/05/2019
SPC Documents
Annex SPC
32
PDF
/3/1/6/2/1/0800412613/docs/300989_1_supplprotectioncertificate20190520030542228.pdf
14/05/2019
SPC Documents
Annex SPC
1
PDF
/3/1/6/2/1/0800412613/docs/300989_2_supplprotectioncertificate20190520030542304.pdf
14/05/2019
SPC Documents
Annex SPC
3
PDF
/3/1/6/2/1/0800412613/docs/300989_3_supplprotectioncertificate20190520030542157.pdf
14/05/2019
Application Form
First filed application form
3
PDF
/3/1/6/2/1/0800412613/docs/300989_5_applicationform20190606095629858.pdf
14/05/2019
SPC Documents
Accompanying letter SPC
3
PDF
/3/1/6/2/1/0800412613/docs/300989_7_supplprotectioncertificate20210122010549220.pdf
14/05/2019
SPC Documents
Annex SPC
9
PDF
/3/1/6/2/1/0800412613/docs/300989_8_supplprotectioncertificate20190520030541942.pdf
14/05/2019
SPC Documents
Summary of the characteristics of the product
16
PDF
/3/1/6/2/1/0800412613/docs/300989_9_supplprotectioncertificate20190520030542083.pdf
14/05/2019
Application Form
First filed application form
3
PDF
/3/1/6/2/1/0800412613/docs/300989_11_applicationform20190520030541646.pdf
14/05/2019
SPC Documents
Marketing Authorization SPC
3
PDF
/3/1/6/2/1/0800412613/docs/300989_12_supplprotectioncertificate20190520030542013.pdf