Patent details

301090 Product Name: Entrectinib, dan wel tautomeren, of farmaceutisch aanvaardbare zouten daarvan

The time of generation of the report may vary depending on the number of the selected files and the pages of each file. If the generation of the consolidated PDF file takes long, you may reduce the number of selected files and proceed with the generation of the PDF in batches.
You have not selected any documents

Basic Information

Publication number:
301090
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2176231
Status:
SPC granted but not yet in force
Application number:
301090
Procedural language:
Dutch
First Applicant Residence Country:
Italy (IT)

Paediatric Extension

SPC Extension Filing Date:
18/06/2025
SPC Extension Agent/Owner Name:
Nerviano Medical Sciences S.r.l. , ir. B.Ch. Ledeboer c.s
SPC Extension Status:
Extension Granted
SPC Extension Grant Date:
22/07/2025
SPC Extension Request Refusal Date:
SPC Extension Revocation Date:

Marketing Authorization

Marketing Authorization Number:
EU/1/20/1460
Marketing Authorization Type:
EEA
Marketing Authorization Date:
03/08/2020
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
27/01/2021
First Marketing Authorization date:
03/08/2020
Grant date:
17/06/2021
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
27/01/2021
SPC/SPC Extension Expiration Date:
07/01/2034
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
27/01/2021
 
 

 

Name:
Nerviano Medical Sciences S.r.l.
Address:
Viale Pasteur, 10, 20014, NERVIANO (MI), Italy (IT)

Agent

Name:
ir. B.Ch. Ledeboer c.s
From:
27/01/2021
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
30/25
Publication date:
28/07/2025
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
26/25
Publication date:
25/06/2025
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

3

Bulletin Heading:
SPC
Journal edition number:
25/21
Publication date:
23/06/2021
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

4

Bulletin Heading:
SPC
Journal edition number:
05/21
Publication date:
03/02/2021
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Annual Fee

Annual Fee(s) Due Date:
31/07/2028
Annual Fee Number:
21
Annual Fee Amount:
1600 Euro
Last Annual Payment Date:
Last Annual Fee Paid Number:
Payer:
Filing date Document type Document Description Number of pages File Type
22/07/2025 Outgoing Correspondence Decision extension duration 1 PDF /1/7/7/8/4/0800648771/docs/301090_27_301090665956l504c.pdf
22/07/2025 Certificate Certificate 1 PDF /1/7/7/8/4/0800648771/docs/301090_28_spcxcertificate20250722080634045.pdf
19/06/2025 SPC Documents Accompanying letter SPC 1 PDF /1/7/7/8/4/0800648771/docs/301090_21_supplprotectioncertificate20250619112439932.pdf
19/06/2025 Outgoing Correspondence Confirmation receipt request for extension 2 PDF /1/7/7/8/4/0800648771/docs/301090_26_661376l505.pdf
18/06/2025 SPC Documents Annex SPC 3 PDF /1/7/7/8/4/0800648771/docs/301090_13_supplprotectioncertificate20250619112048763.pdf
18/06/2025 SPC Documents Annex SPC 1 PDF /1/7/7/8/4/0800648771/docs/301090_14_supplprotectioncertificate20250619112117814.pdf
18/06/2025 SPC Documents Marketing Authorization SPC 3 PDF /1/7/7/8/4/0800648771/docs/301090_15_supplprotectioncertificate20250619112004353.pdf
18/06/2025 SPC Documents Annex SPC 44 PDF /1/7/7/8/4/0800648771/docs/301090_16_supplprotectioncertificate20250619112144288.pdf
18/06/2025 SPC Documents Marketing Authorization SPC 3 PDF /1/7/7/8/4/0800648771/docs/301090_17_supplprotectioncertificate20250619112303690.pdf
18/06/2025 SPC Documents Certificate SPC 1 PDF /1/7/7/8/4/0800648771/docs/301090_18_supplprotectioncertificate20250619112246597.pdf
18/06/2025 SPC Documents Annex SPC 44 PDF /1/7/7/8/4/0800648771/docs/301090_19_supplprotectioncertificate20250619112329220.pdf
18/06/2025 SPC Documents Summary of the characteristics of the product 63 PDF /1/7/7/8/4/0800648771/docs/301090_20_supplprotectioncertificate20250619112543955.pdf
18/06/2025 SPC Documents Annex SPC 3 PDF /1/7/7/8/4/0800648771/docs/301090_22_supplprotectioncertificate20250619112211207.pdf
18/06/2025 Application Form First filed application form 3 PDF /1/7/7/8/4/0800648771/docs/301090_23_applicationform20250619111801207.pdf
18/06/2025 SPC Documents Summary of the characteristics of the product 63 PDF /1/7/7/8/4/0800648771/docs/301090_24_supplprotectioncertificate20250619112417602.pdf
18/06/2025 SPC Documents Annex SPC 2 PDF /1/7/7/8/4/0800648771/docs/301090_25_supplprotectioncertificate20250619112354624.pdf
17/06/2021 Certificate Certificate 1 PDF /1/7/7/8/4/0800648771/docs/301090_0_spcmedcertificate20210617113056324.pdf
17/06/2021 Outgoing Correspondence Decision grant 1 PDF /1/7/7/8/4/0800648771/docs/301090_4_417829l504a.pdf
11/06/2021 Incoming Correspondence Paper Accompanying letter incoming document 1 PDF /1/7/7/8/4/0800648771/docs/301090_12_incomingcorrespondencepaper20210614080157882.pdf
18/03/2021 Outgoing Correspondence Letter to applicant 3 PDF /1/7/7/8/4/0800648771/docs/301090_1_398266l173.pdf
18/03/2021 SPC Documents Annex SPC 7 PDF /1/7/7/8/4/0800648771/docs/301090_10_supplprotectioncertificate20210318100817514.pdf
27/01/2021 SPC Documents Accompanying letter SPC 1 PDF /1/7/7/8/4/0800648771/docs/301090_2_supplprotectioncertificate20210127123046357.pdf
27/01/2021 Outgoing Correspondence Confirmation receipt request 1 PDF /1/7/7/8/4/0800648771/docs/301090_3_391925l174.pdf
27/01/2021 SPC Documents Annex SPC 3 PDF /1/7/7/8/4/0800648771/docs/301090_5_supplprotectioncertificate20210127123410417.pdf
27/01/2021 SPC Documents Marketing Authorization SPC 3 PDF /1/7/7/8/4/0800648771/docs/301090_6_supplprotectioncertificate20210127123143977.pdf
27/01/2021 SPC Documents Annex SPC 2 PDF /1/7/7/8/4/0800648771/docs/301090_7_supplprotectioncertificate20210127123558531.pdf
27/01/2021 SPC Documents Annex SPC 20 PDF /1/7/7/8/4/0800648771/docs/301090_8_supplprotectioncertificate20210127123520835.pdf
27/01/2021 Application Form First filed application form 3 PDF /1/7/7/8/4/0800648771/docs/301090_9_applicationform20210127122719136.pdf
27/01/2021 SPC Documents Summary of the characteristics of the product 27 PDF /1/7/7/8/4/0800648771/docs/301090_11_supplprotectioncertificate20210127123309418.pdf