Patent details
301128 Product Name: Risdiplam of een farmaceutisch aanvaardbaar zout daarvan
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Basic Information
- Publication number:
- 301128
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP3143025
- Status:
- SPC granted but not yet in force
- Application number:
- 301128
- Procedural language:
- Dutch
- First Applicant Residence Country:
- Switzerland (CH)
Paediatric Extension
- SPC Extension Filing Date:
- 19/08/2025
- SPC Extension Agent/Owner Name:
- F. Hoffmann-La Roche AG , PTC Therapeutics, Inc. , ir. B.Ch. Ledeboer c.s
- SPC Extension Status:
- Extension Granted
- SPC Extension Grant Date:
- 28/08/2025
- SPC Extension Request Refusal Date:
- SPC Extension Revocation Date:
Marketing Authorization
- Marketing Authorization Number:
- EU/1/21/1531
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 29/03/2021
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 15/09/2021
- First Marketing Authorization date:
- 29/03/2021
- Grant date:
- 25/10/2021
- Activation date:
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 20/09/2021
- SPC/SPC Extension Expiration Date:
- 28/09/2036
- Lapsed By Expiration Date:
- Withdrawal date:
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 23/09/2025
- Name:
- PTC Therapeutics, Inc.
- Address:
- 500 Warren Corporate Center Drive, 07059, Warren, New Jersey, United States of America (US)
- From:
- 15/09/2021
- Name:
- F. Hoffmann-La Roche AG
- Address:
- Grenzacherstrasse 124, 4070, BASEL, Switzerland (CH)
Historical Applicant/holder
- From:
- 15/09/2021
- To:
- 18/09/2025
- Name:
- PTC Therapeutics, Inc.
- Address:
- 100 Corporate Court,, 07080, SOUTH PLAINFIELD, NJ , United States of America (US)
Agent
- Name:
- ir. B.Ch. Ledeboer c.s
- From:
- 15/09/2021
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
Publication
Bulletin
1
- Bulletin Heading:
- SPC
- Journal edition number:
- 36/25
- Publication date:
- 03/09/2025
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 35/25
- Publication date:
- 27/08/2025
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
- Bulletin Heading:
- SPC
- Journal edition number:
- 43/21
- Publication date:
- 27/10/2021
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
- Bulletin Heading:
- SPC
- Journal edition number:
- 38/21
- Publication date:
- 22/09/2021
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Deed
Change of Address
- Change Kind/ Decision Type:
- Owner
- Deed Number:
- RC202501561A
- Date Registered:
- 18/09/2025
- License Effective Date:
- License Expiration Date:
- Scope of License:
- Deed Filer:
- ir. B.Ch. Ledeboer c.s
- Journal Edition Number:
- Text:
- Deed Status:
- Country Code:
- Updated License Number:
- Terminated License Number:
Changed Pledgee
- Name:
- Address:
Removed Usufructuary
- Name:
- Address:
Added Usufructuary
- Name:
- Address:
Changed Usufructuary
- Name:
- Address:
Annual Fee
- Annual Fee(s) Due Date:
- 31/05/2035
- 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 | ||
|---|---|---|---|---|---|---|
| 28/08/2025 | Outgoing Correspondence | Decision extension duration | 1 | /9/9/0/5/2/0800725099/docs/301128_19_301128671673l504c.pdf | ||
| 28/08/2025 | Certificate | Certificate | 1 | /9/9/0/5/2/0800725099/docs/301128_20_spcxcertificate20250828125218378.pdf | ||
| 21/08/2025 | Outgoing Correspondence | Confirmation receipt request for extension | 2 | /9/9/0/5/2/0800725099/docs/301128_9_301128670408l505.pdf | ||
| 19/08/2025 | Application Form | First filed application form | 3 | /9/9/0/5/2/0800725099/docs/301128_10_applicationform20250820110312121.pdf | ||
| 19/08/2025 | SPC Documents | Annex SPC | 1 | /9/9/0/5/2/0800725099/docs/301128_11_supplprotectioncertificate20250820110312179.pdf | ||
| 19/08/2025 | SPC Documents | Accompanying letter SPC | 1 | /9/9/0/5/2/0800725099/docs/301128_12_supplprotectioncertificate20250820110312155.pdf | ||
| 19/08/2025 | SPC Documents | Marketing Authorization SPC | 3 | /9/9/0/5/2/0800725099/docs/301128_13_supplprotectioncertificate20250820110312196.pdf | ||
| 19/08/2025 | SPC Documents | Summary of the characteristics of the product | 43 | /9/9/0/5/2/0800725099/docs/301128_14_supplprotectioncertificate20250820110312204.pdf | ||
| 19/08/2025 | SPC Documents | Marketing Authorization SPC | 3 | /9/9/0/5/2/0800725099/docs/301128_15_supplprotectioncertificate20250820110312188.pdf | ||
| 19/08/2025 | SPC Documents | Annex SPC | 30 | /9/9/0/5/2/0800725099/docs/301128_16_supplprotectioncertificate20250820110312164.pdf | ||
| 19/08/2025 | SPC Documents | Annex SPC | 41 | /9/9/0/5/2/0800725099/docs/301128_17_supplprotectioncertificate20250820110312233.pdf | ||
| 19/08/2025 | SPC Documents | Annex SPC | 3 | /9/9/0/5/2/0800725099/docs/301128_18_supplprotectioncertificate20250820110312222.pdf | ||
| 25/10/2021 | Outgoing Correspondence | Decision grant | 2 | /9/9/0/5/2/0800725099/docs/301128_1_442246l504a.pdf | ||
| 25/10/2021 | Certificate | Certificate | 1 | /9/9/0/5/2/0800725099/docs/301128_6_spcmedcertificate20211025173724709.pdf | ||
| 22/09/2021 | Outgoing Correspondence | Confirmation receipt request | 1 | /9/9/0/5/2/0800725099/docs/301128_3_436419l174.pdf | ||
| 15/09/2021 | SPC Documents | Annex SPC | 3 | /9/9/0/5/2/0800725099/docs/301128_0_supplprotectioncertificate20210915123955671.pdf | ||
| 15/09/2021 | SPC Documents | Annex SPC | 120 | /9/9/0/5/2/0800725099/docs/301128_2_supplprotectioncertificate20210915123955790.pdf | ||
| 15/09/2021 | SPC Documents | Summary of the characteristics of the product | 19 | /9/9/0/5/2/0800725099/docs/301128_4_supplprotectioncertificate20210915123955615.pdf | ||
| 15/09/2021 | SPC Documents | Annex SPC | 26 | /9/9/0/5/2/0800725099/docs/301128_5_supplprotectioncertificate20210915123955724.pdf | ||
| 15/09/2021 | Application Form | First filed application form | 3 | /9/9/0/5/2/0800725099/docs/301128_7_applicationform20210915123955362.pdf | ||
| 15/09/2021 | SPC Documents | Marketing Authorization SPC | 3 | /9/9/0/5/2/0800725099/docs/301128_8_supplprotectioncertificate20210915123955546.pdf |