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Patent details

2021C530 Product name: drospirénone en combinaison avec estétrol

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Basic information

Application number:
2021C/530
Type:
Certificate
SPC type:
Medical
Basic patent number:
027389618
Status:
Active
Publication number:
2021C530
1rst applicant's nationality:
Procedural language:
French

Paediatric extension

SPC Extension filing date:
16/04/2025
SPC Extension agent/owner name:
DE CLERCQ & PARTNERS CV
SPC Extension status:
Open & Published
SPC Extension grant date:
SPC Extension Rejection Date:

Marketing authorization

Marketing authorization number:
EU/1/21/1548, EU/1/21/1547
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
20/05/2021
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
29/07/2021
First marketing authorization date:
20/05/2021
Grant date:
09/08/2021
Activation date:
23/05/2022
BE Publication date:
30/07/2021
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
23/05/2027
SPC/SPC Extension Expiration (if granted and all annual fees paid):
23/11/2027
Rejection date:
Withdrawal date:

Applicant

Name:
Estetra
Legal Form:
SRL : société à responsabilité limitée
From:
30/07/2021
Address:
Rue Saint-Georges 5, 4000, Liège, Belgium (BE)
To:

Agent

Name:
DE CLERCQ & PARTNERS CV
Legal Form:
From:
30/07/2021
Address:
Ed. Gevaertdreef 10a, 9830, ST MARTENS LATEM, Belgium (BE)
To:

Publication

Bulletin

1

Bulletin heading:
MED
Journal edition number:
2023/02
Publication date:
08/02/2023
Description:
Contains data concerning other communications

2

Bulletin heading:
SPC
Journal edition number:
2021/14
Publication date:
18/08/2021
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

3

Bulletin heading:
SPC
Journal edition number:
2021/16
Publication date:
30/09/2021
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

4

Bulletin heading:
SPC
Journal edition number:
2022/10
Publication date:
13/06/2022
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

5

Bulletin heading:
MED
Journal edition number:
2025/02
Publication date:
21/03/2025
Description:
Contains data concerning other communications

6

Bulletin heading:
SPC
Journal edition number:
2025/11
Publication date:
07/08/2025
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Deed

Right of Pledge

Change Kind / Decision Type:
Established
Deed number:
RC2022100896A
Registration date:
27/09/2022
License effective date:
License expiration date:
Scope of license:
Deed filer:
DE CLERCQ & PARTNERS CV
Bulletin edition number:
Text:
Country code:
Updated license number:
Terminated license number:

Removed pledgee

Name:
Address:

Changed pledgee

Name:
Address:

Removed usufructuary

Name:
Address:

Added usufructuary

Name:
Address:

Changed usufructuary

Name:
Address:

Right of Pledge

Change Kind / Decision Type:
Removed
Deed number:
RC2025000020A
Registration date:
19/09/2024
License effective date:
License expiration date:
Scope of license:
Deed filer:
DE CLERCQ & PARTNERS CV
Bulletin edition number:
Text:
Country code:
Updated license number:
Terminated license number:

Removed pledgee

Name:
Address:

Changed pledgee

Name:
Address:

Removed usufructuary

Name:
Address:

Added usufructuary

Name:
Address:

Changed usufructuary

Name:
Address:

Annual fee

Annual fee(s) Due Date:
01/06/2026
Annual fee number:
25
Annual fee amount:
850 Euro
Expected payer:
Last annual fee payment date:
27/03/2025
Last annual fee paid number:
24
Last annual fee paid amount:
800 Euro
Payer:
PAVIS GmbH
Filing date Document type Publication Type Document Description Number of pages File Type
29/07/2021 General Document Other 4 PDF /0/6/6/6/4/0722146660/docs/2021c530_0_generaldocument_20210730_084806211.pdf
30/07/2021 Publication I1 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_1_i1document_20210730_105145792.pdf
29/07/2021 Marketing Authorization 1st Marketing Authorization (EU) 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_2_marketingauthorization_20210730_084809864.pdf
29/07/2021 Application Form 4 PDF /0/6/6/6/4/0722146660/docs/2021c530_3_applicationform_20210730_084811725.pdf
29/07/2021 Abstract Product Characteristics Abstract of the characteristics of the product 52 PDF /0/6/6/6/4/0722146660/docs/2021c530_4_abstractproductcharacteristics_20210730_084807836.pdf
30/07/2021 Outgoing Correspondence 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_5_outgoingcorrespondence_20210804_093712819.pdf
09/08/2021 Certificate 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_6_spc_medcertificate_20210809_100409037.pdf
09/08/2021 Front Page 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_7_i2frontpage_20210809_100407616.pdf
29/07/2021 General Document Other 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_8_generaldocument_20210730_084807514.pdf
29/07/2021 General Document Other 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_9_generaldocument_20210730_084806649.pdf
29/07/2021 MA Official Publication Official Publication of 1st Marketing Authorization 7 PDF /0/6/6/6/4/0722146660/docs/2021c530_10_maofficialpublication_20210730_084808866.pdf
27/09/2022 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_11_rfc_20220928_084554317.pdf
27/09/2022 Request For Change Free translation of the deed or extract 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_12_rfc_20220928_084554423.pdf
19/01/2023 Request For Change Usufruct agreement 11 PDF /0/6/6/6/4/0722146660/docs/2021c530_13_rfc_20230120_084605313.pdf
19/01/2023 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_14_rfc_20230120_084605618.pdf
27/09/2022 Outgoing Correspondence 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_15_outgoingcorrespondence_20220928_084554179.pdf
13/10/2022 Outgoing Correspondence 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_16_outgoingcorrespondence_20221026_020232852.pdf
19/01/2023 Outgoing Correspondence 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_17_outgoingcorrespondence_20230120_084604522.pdf
27/09/2022 Request For Change Deed or extract allowing the change 55 PDF /0/6/6/6/4/0722146660/docs/2021c530_18_rfc_20220928_084554583.pdf
19/01/2023 Request For Change Power of attorney deed 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_19_rfc_20230120_084605065.pdf
19/01/2023 Request For Change Free translation of the deed or extract 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_20_rfc_20230120_084605222.pdf
27/09/2022 Incoming Correspondence (Email) Cover letter 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_21_incomingcorrespondenceelectronic_20220928_084556760.pdf
19/01/2023 Incoming Correspondence (Email) Cover letter 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_22_incomingcorrespondenceelectronic_20230120_084605775.pdf
30/07/2021 Front Page 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_23_i1frontpage_20210730_105145341.pdf
09/08/2021 Publication I2 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_24_i2document_20210809_100408459.pdf
29/07/2021 General Document Other 51 PDF /0/6/6/6/4/0722146660/docs/2021c530_25_generaldocument_20210730_084806996.pdf
29/07/2021 General Document Other 22 PDF /0/6/6/6/4/0722146660/docs/2021c530_26_generaldocument_20210730_084810774.pdf
09/08/2021 Outgoing Correspondence 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_27_outgoingcorrespondence_20210811_090341267.pdf
19/09/2024 Request For Change Letter and/or Form requesting a change in the Register 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_28_rfc_20250130_031749179.pdf
19/09/2024 Request For Change Deed or extract allowing the change 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_29_rfc_20250130_031903294.pdf
19/09/2024 Request For Change Deed or extract allowing the change 5 PDF /0/6/6/6/4/0722146660/docs/2021c530_30_rfc_20250130_031946993.pdf
19/09/2024 Request For Change Document with several annexes 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_31_rfc_20250130_032136059.pdf
19/09/2024 Request For Change Document with several annexes 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_32_rfc_20250130_032205992.pdf
31/01/2025 Outgoing Correspondence Outgoing Correspondence 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_33_209971_pie.xi.52.mg.notif.pdf
18/06/2025 Outgoing Correspondence 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_34_outgoingcorrespondence_20250618_031752994.pdf
16/04/2025 Marketing Authorization 1st Paediatric Marketing Authorization (EU) 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_35_marketingauthorization_20250417_084522929.pdf
16/04/2025 Application Form 5 PDF /0/6/6/6/4/0722146660/docs/2021c530_36_applicationform_20250417_084524422.pdf
16/04/2025 General Document Other 13 PDF /0/6/6/6/4/0722146660/docs/2021c530_37_generaldocument_20250417_084522528.pdf
16/04/2025 Paediatric Investigation Plan Paediatric Investigation Plan (PIP) 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_38_paediatricinvestigationplan_20250417_084523966.pdf
16/04/2025 General Document Other 53 PDF /0/6/6/6/4/0722146660/docs/2021c530_39_generaldocument_20250417_084522717.pdf
16/04/2025 General Document Other 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_40_generaldocument_20250417_084524316.pdf
16/04/2025 General Document Other 3 PDF /0/6/6/6/4/0722146660/docs/2021c530_41_generaldocument_20250417_084522398.pdf
07/08/2025 Request For Change Letter and/or Form requesting a change in the Register 2 PDF /0/6/6/6/4/0722146660/docs/2021c530_42_rfc_20250915_113619697.pdf
07/08/2025 Request For Change Letter of regularisation of a change 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_43_rfc_20250915_114250739.pdf
15/09/2025 Outgoing Correspondence Outgoing Correspondence 1 PDF /0/6/6/6/4/0722146660/docs/2021c530_44_221547_pie.rfc.man.notif.pdf