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