Patent details

300597 Product Name: Insuline degludec en insuline aspart.

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Basic Information

Publication number:
300597
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2107069
Status:
SPC in force
Application number:
300597
Procedural language:
Dutch
First Applicant Residence Country:

Paediatric Extension

SPC Extension Filing Date:
20/12/2023
SPC Extension Agent/Owner Name:
ir. M.F.J.M. Ketelaars c.s. , NOVO NORDISK A/S
SPC Extension Status:
Extension Granted
SPC Extension Grant Date:
28/12/2023
SPC Extension Request Refusal Date:
SPC Extension Revocation Date:

Marketing Authorization

1

Marketing Authorization Number:
EU/1/12/806/008
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/01/2013
Marketing Authorization Country:
European Union (EU)

2

Marketing Authorization Number:
EU/1/12/806/007
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/01/2013
Marketing Authorization Country:
European Union (EU)

3

Marketing Authorization Number:
EU/1/12/806/005
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/01/2013
Marketing Authorization Country:
European Union (EU)

4

Marketing Authorization Number:
EU/1/12/806/004
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/01/2013
Marketing Authorization Country:
European Union (EU)

5

Marketing Authorization Number:
EU/1/12/806/001
Marketing Authorization Type:
EEA
Marketing Authorization Date:
23/01/2013
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
18/06/2013
First Marketing Authorization date:
23/01/2013
Grant date:
03/06/2014
Activation date:
22/07/2024
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
18/06/2013
SPC/SPC Extension Expiration Date:
22/07/2028
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
18/06/2013
 
 

 

Name:
NOVO NORDISK A/S
Address:
Novo Allé, 2880 BAGSVÆRD, Denmark (DK)

Agent

Name:
ir. M.F.J.M. Ketelaars c.s.
From:
18/06/2013
Address:
NLO Postbus 29720, 2502 LS, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
30/24
Publication date:
24/07/2024
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
01/24
Publication date:
03/01/2024
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

3

Bulletin Heading:
SPC
Journal edition number:
52/23
Publication date:
27/12/2023
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

4

Bulletin Heading:
SPC
Journal edition number:
2014/25
Publication date:
18/06/2014
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

5

Bulletin Heading:
SPC
Journal edition number:
2013/26
Publication date:
26/06/2013
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Annual Fee

Annual Fee(s) Due Date:
31/07/2026
Annual Fee Number:
23
Annual Fee Amount:
2000 Euro
Last Annual Payment Date:
20/06/2025
Last Annual Fee Paid Number:
22
Last Annual Fee Paid Amount:
1800 Euro
Payer:
Anaqua Services
Filing date Document type Document Description Number of pages File Type
28/12/2023 Outgoing Correspondence Decision extension duration 1 PDF /7/9/5/0/0/0400300597/docs/300597_21_583216l504c.pdf
28/12/2023 Certificate Certificate 1 PDF /7/9/5/0/0/0400300597/docs/300597_22_spcxcertificate20231228112358767.pdf
22/12/2023 Outgoing Correspondence Confirmation receipt request for extension 2 PDF /7/9/5/0/0/0400300597/docs/300597_20_582660l505.pdf
20/12/2023 Application Form First filed application form 2 PDF /7/9/5/0/0/0400300597/docs/300597_15_applicationform20231221023544232.pdf
20/12/2023 SPC Documents Marketing Authorization SPC 3 PDF /7/9/5/0/0/0400300597/docs/300597_16_supplprotectioncertificate20231221023657738.pdf
20/12/2023 SPC Documents Certificate SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_17_supplprotectioncertificate20231221023623666.pdf
20/12/2023 SPC Documents Annex SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_18_supplprotectioncertificate20231221023734874.pdf
20/12/2023 SPC Documents Summary of the characteristics of the product 15 PDF /7/9/5/0/0/0400300597/docs/300597_19_supplprotectioncertificate20231221030100197.pdf
05/01/2016 SPC Documents Certificate SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_0_supplprotectioncertificate20201001102611409.pdf
05/01/2016 Outgoing Correspondence Decision grant 1 PDF /7/9/5/0/0/0400300597/docs/300597_5_outgoingcorrespondence20201001102413193.pdf
23/11/2015 SPC Documents Accompanying letter SPC 2 PDF /7/9/5/0/0/0400300597/docs/300597_8_supplprotectioncertificate20201001102203238.pdf
23/11/2015 SPC Documents Annex SPC 7 PDF /7/9/5/0/0/0400300597/docs/300597_13_supplprotectioncertificate20201001102046007.pdf
03/06/2014 SPC Documents Certificate SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_1_supplprotectioncertificate20201001101803418.pdf
03/06/2014 Outgoing Correspondence Outgoing Letter 1 PDF /7/9/5/0/0/0400300597/docs/300597_14_outgoingcorrespondence20140603.pdf
29/05/2014 SPC Documents Accompanying letter SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_11_supplprotectioncertificate20201001101452732.pdf
08/04/2014 Outgoing Correspondence Outgoing Letter 3 PDF /7/9/5/0/0/0400300597/docs/300597_3_outgoingcorrespondence20140408.pdf
26/02/2014 SPC Documents Accompanying letter SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_4_supplprotectioncertificate20201001101249857.pdf
27/08/2013 Outgoing Correspondence Outgoing Letter 1 PDF /7/9/5/0/0/0400300597/docs/300597_6_outgoingcorrespondence20130827.pdf
19/06/2013 Outgoing Correspondence Outgoing Letter 1 PDF /7/9/5/0/0/0400300597/docs/300597_2_outgoingcorrespondence20130619.pdf
18/06/2013 Application Form First filed application form 2 PDF /7/9/5/0/0/0400300597/docs/300597_7_applicationform20130618.pdf
18/06/2013 SPC Documents Marketing Authorization SPC 4 PDF /7/9/5/0/0/0400300597/docs/300597_9_supplprotectioncertificate20201001100310043.pdf
18/06/2013 SPC Documents Accompanying letter SPC 1 PDF /7/9/5/0/0/0400300597/docs/300597_10_supplprotectioncertificate20201001094414747.pdf
18/06/2013 SPC Documents Summary of the characteristics of the product 27 PDF /7/9/5/0/0/0400300597/docs/300597_12_supplprotectioncertificate20201001100956787.pdf