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Patent details

2013C035 Product name: INSULINE DEGLUDEC.

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Basic information

Application number:
2013C/035
Type:
Certificate
SPC type:
Medical
Basic patent number:
091650721
Status:
Active
Publication number:
2013C035
1rst applicant's nationality:
Procedural language:
French

Paediatric extension

SPC Extension filing date:
11/04/2024
SPC Extension agent/owner name:
OFFICE FREYLINGER S.A.
SPC Extension status:
Open & Published
SPC Extension grant date:
SPC Extension Rejection Date:

Marketing authorization

Marketing authorization number:
EU/1/12/807/001
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
23/01/2013
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
11/06/2013
First marketing authorization date:
23/01/2013
Grant date:
14/12/2023
Activation date:
22/07/2024
BE Publication date:
06/06/2018
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
23/01/2028
SPC/SPC Extension Expiration (if granted and all annual fees paid):
23/07/2028
Rejection date:
Withdrawal date:

Applicant

Name:
NOVO NORDISK A/S.
Legal Form:
From:
11/06/2013
Address:
Novo Allé, 2880, Bagsværd, Denmark (DK)
To:

Agent

Name:
KIHN Pierre
Legal Form:
From:
11/06/2013
Address:
Route d'Arlon 234 P.O. Box 48, 8001, STRASSEN, Luxembourg (LU)
To:

Publication

Bulletin

1

Bulletin heading:
SPC
Journal edition number:
2018/14
Publication date:
22/08/2018
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

2

Bulletin heading:
SPC
Journal edition number:
2023/23
Publication date:
10/01/2024
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

3

Bulletin heading:
SPC
Journal edition number:
2024/07
Publication date:
06/05/2024
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

4

Bulletin heading:
SPC
Journal edition number:
2024/14
Publication date:
05/08/2024
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
31/07/2025
Annual fee number:
22
Annual fee amount:
700 Euro
Expected payer:
Last annual fee payment date:
19/06/2024
Last annual fee paid number:
21
Last annual fee paid amount:
650 Euro
Payer:
ANAQUA SERVICES
Filing date Document type Publication Type Document Description Number of pages File Type
14/12/2023 Outgoing Correspondence 2 PDF /5/3/0/3/1/0300013035/docs/2013c035_0_outgoingcorrespondence_20231220_095845869.pdf
06/06/2018 Publication I1 1 PDF /5/3/0/3/1/0300013035/docs/2013c035_1_i1document_20180606_141532599.pdf
14/12/2023 Publication I2 1 PDF /5/3/0/3/1/0300013035/docs/2013c035_2_i2document_20231214_102559861.pdf
12/04/2024 Outgoing Correspondence 2 PDF /5/3/0/3/1/0300013035/docs/2013c035_3_outgoingcorrespondence_20240422_011237620.pdf
12/04/2024 Publication I1E 1 PDF /5/3/0/3/1/0300013035/docs/2013c035_4_i1edocument_20240412_094529715.pdf
11/04/2024 Application Form 3 PDF /5/3/0/3/1/0300013035/docs/2013c035_5_applicationform_20240412_084530399.pdf
11/04/2024 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 3 PDF /5/3/0/3/1/0300013035/docs/2013c035_6_marketingauthorization_20240412_084529404.pdf
11/04/2024 General Document Other 2 PDF /5/3/0/3/1/0300013035/docs/2013c035_7_generaldocument_20240412_084529917.pdf
11/04/2024 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 21 PDF /5/3/0/3/1/0300013035/docs/2013c035_8_paediatricinvestigationplan_20240412_084530050.pdf
11/04/2024 General Document Other 92 PDF /5/3/0/3/1/0300013035/docs/2013c035_9_generaldocument_20240412_084529638.pdf
17/10/2024 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 3 PDF /5/3/0/3/1/0300013035/docs/2013c035_10_paediatricinvestigationplan_20241018_084607497.pdf
17/10/2024 Incoming Correspondence (Email) Cover letter 1 PDF /5/3/0/3/1/0300013035/docs/2013c035_11_incomingcorrespondenceelectronic_20241018_084607381.pdf