Patent details

300643 Product Name: Afatinib, desgewenst in de vorm van een zout, in het bijzonder fysiologisch aanvaardbare zouten met anorganische of organische zuren of basen, meer in het bijzonder zouten met maleïnezuur, met name afatinib dimaleaat.

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Basic Information

Publication number:
300643
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP1345910
Status:
SPC in force
Application number:
300643
Procedural language:
Dutch
First Applicant Residence Country:

Paediatric Extension

SPC Extension Filing Date:
12/05/2022
SPC Extension Agent/Owner Name:
ir. F.A. Geurts c.s. , Boehringer Ingelheim Pharma GmbH & Co.KG
SPC Extension Status:
Extension Granted
SPC Extension Grant Date:
16/05/2022
SPC Extension Request Refusal Date:
SPC Extension Revocation Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/13/879/001-012
Marketing Authorization Type:
EEA
Marketing Authorization Date:
27/09/2013
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
14/02/2014
First Marketing Authorization date:
27/09/2013
Grant date:
24/09/2014
Activation date:
12/12/2021
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
14/02/2014
SPC/SPC Extension Expiration Date:
11/06/2027
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
14/02/2014
 
 

 

Name:
Boehringer Ingelheim Pharma GmbH & Co.KG
Address:
Binger Strasse 173, 55218, Ingelheim am Rhein, Germany (DE)

Agent

Name:
ir. F.A. Geurts c.s.
From:
14/02/2014
Address:
Octrooibureau Vriesendorp & Gaade B.V. Koninginnegracht 19, 2514 AB, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
20/22
Publication date:
18/05/2022
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
20/22
Publication date:
18/05/2022
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

3

Bulletin Heading:
SPC
Journal edition number:
50/21
Publication date:
15/12/2021
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

4

Bulletin Heading:
SPC
Journal edition number:
2014/40
Publication date:
01/10/2014
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

5

Bulletin Heading:
SPC
Journal edition number:
2014/09
Publication date:
26/02/2014
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Annual Fee

Annual Fee(s) Due Date:
31/12/2026
Annual Fee Number:
26
Annual Fee Amount:
1300 Euro
Last Annual Payment Date:
10/12/2025
Last Annual Fee Paid Number:
25
Last Annual Fee Paid Amount:
2400 Euro
Payer:
Dennemeyer and Co
Filing date Document type Document Description Number of pages File Type
16/05/2022 Outgoing Correspondence Confirmation receipt request for extension 1 PDF /3/4/6/0/0/0400300643/docs/300643_13_480071l505.pdf
16/05/2022 Outgoing Correspondence Decision extension duration 1 PDF /3/4/6/0/0/0400300643/docs/300643_14_480474l504c.pdf
16/05/2022 Certificate Certificate 1 PDF /3/4/6/0/0/0400300643/docs/300643_15_spcxcertificate20220516110453015.pdf
12/05/2022 SPC Documents Annex SPC 1 PDF /3/4/6/0/0/0400300643/docs/300643_12_supplprotectioncertificate20220513095506521.pdf
12/05/2022 Application Form First filed application form 4 PDF /3/4/6/0/0/0400300643/docs/300643_16_applicationform20220513095027292.pdf
12/05/2022 SPC Documents Summary of the characteristics of the product 26 PDF /3/4/6/0/0/0400300643/docs/300643_17_supplprotectioncertificate20220513095351591.pdf
12/05/2022 SPC Documents Annex SPC 1 PDF /3/4/6/0/0/0400300643/docs/300643_18_supplprotectioncertificate20220513095718758.pdf
12/05/2022 SPC Documents Marketing Authorization SPC 3 PDF /3/4/6/0/0/0400300643/docs/300643_19_supplprotectioncertificate20220513095430428.pdf
31/08/2016 SPC Documents Annex SPC 1 PDF /3/4/6/0/0/0400300643/docs/300643_5_supplprotectioncertificate20201008013236393.pdf
31/08/2016 SPC Documents Accompanying letter SPC 1 PDF /3/4/6/0/0/0400300643/docs/300643_8_supplprotectioncertificate20201008013106660.pdf
18/09/2014 Outgoing Correspondence Outgoing Letter 1 PDF /3/4/6/0/0/0400300643/docs/300643_6_outgoingcorrespondence20140918.pdf
18/09/2014 SPC Documents Certificate SPC 1 PDF /3/4/6/0/0/0400300643/docs/300643_9_supplprotectioncertificate20201008012739551.pdf
22/07/2014 SPC Documents Accompanying letter SPC 2 PDF /3/4/6/0/0/0400300643/docs/300643_3_supplprotectioncertificate20201008012514729.pdf
22/07/2014 SPC Documents Annex SPC 24 PDF /3/4/6/0/0/0400300643/docs/300643_7_supplprotectioncertificate20201008012413774.pdf
22/04/2014 Outgoing Correspondence Outgoing Letter 1 PDF /3/4/6/0/0/0400300643/docs/300643_4_outgoingcorrespondence20140422.pdf
18/02/2014 Outgoing Correspondence Outgoing Letter 1 PDF /3/4/6/0/0/0400300643/docs/300643_11_outgoingcorrespondence20140218.pdf
14/02/2014 SPC Documents Summary of the characteristics of the product 61 PDF /3/4/6/0/0/0400300643/docs/300643_0_supplprotectioncertificate20201008011730096.pdf
14/02/2014 SPC Documents Annex SPC 4 PDF /3/4/6/0/0/0400300643/docs/300643_1_supplprotectioncertificate20201008011856504.pdf
14/02/2014 Application Form First filed application form 3 PDF /3/4/6/0/0/0400300643/docs/300643_2_applicationform20140214.pdf
14/02/2014 SPC Documents Marketing Authorization SPC 3 PDF /3/4/6/0/0/0400300643/docs/300643_10_supplprotectioncertificate20201008011227879.pdf