Patent details
LUC00191 Product Name: Entrectinib ou les isomères, tautomères, ou sels pharmaceutiquement acceptables de celui-ci
Basic Information
- Publication number:
- LUC00191
- Type:
- SPC
- SPC Type:
- Medical
- Basic Patent Number:
- EP087859757
- Legal Status:
- Inactive
- Application number:
- LUC00191
- First applicant's nationality:
- Procedural language:
- French
Paediatric Extension
- SPC Extension Filing Date:
- 18/06/2025
- SPC Extension Agent Name:
- OFFICE FREYLINGER S.A.
- SPC Extension Status:
- Pending & Published
- SPC Extension Grant Date:
- SPC Extension Rejection Date:
Marketing Authorization
- Marketing Authorization Number:
- EU/1/20/1460
- Marketing Authorization Type:
- Marketing Authorization Date:
- 03/08/2020
- Marketing Authorization Status:
- Accepted
- Marketing Authorization Country:
- Luxembourg (LU)
Dates
- Filing date:
- 10/12/2020
- First Marketing Authorization date:
- 03/08/2020
- Grant date:
- 14/12/2021
- Activation date:
- Publication date:
- 15/12/2020
- Lapsed date:
- Expiration date:
- Renunciation date:
- Revocation date:
- Annulment date:
- Basic SPC Expiration:
- 08/07/2033
- SPC Extension Expiration:
- 08/01/2034
- Rejection date:
- Withdrawal date:
Owner
- From:
- 10/12/2020
- Name:
- Nerviano Medical Sciences S.r.l.
- Address:
- Viale Pasteur, 10, 20014 Nerviano (MI), Italy (IT)
Agent
- Name:
- OFFICE FREYLINGER S.A.
- From:
- 10/12/2020
- Address:
- Boîte Postale 48, L-8001, STRASSEN, Luxembourg (LU)
- To:
Publication
Bulletin
1
- Bulletin Heading:
- SPC1
- Bulletin edition number:
- 2021/01
- Publication date:
- 05/01/2021
- Description:
- Section C : Published requests for Supplementary Protection Certificates – I1 publication
2
- Bulletin Heading:
- SPC2
- Bulletin edition number:
- 2022/01
- Publication date:
- 03/01/2022
- Description:
- Section D : Granted supplementary protection certificates – I2 publication
3
- Bulletin Heading:
- SPCX1
- Bulletin edition number:
- 2025/08
- Publication date:
- 03/07/2025
- Description:
- Section G : Applications for extensions for pediatric use – I1E publication
Annual Fees
- Annual Fee Due Date:
- 31/07/2028
- Annual Fee Number:
- 21
- Annual Fee Amount:
- 410 Euro
- Expected Payer:
- Last Annual Fee Payment Date:
- Last Annual Fee Paid Number:
- Payer:
| Filing date | Document type | Number of pages |
|---|---|---|
| 10/12/2020 | Summary of the product caracteristics | 52 |
| 15/12/2020 | Publication | 1 |
| 10/12/2020 | Marketing authorization | 3 |
| 14/12/2021 | Publication | 1 |
| 14/12/2021 | Outgoing Correspondence | 1 |
| 10/12/2020 | Application Form | 4 |
| 15/12/2020 | Outgoing Correspondence | 1 |
| 10/12/2020 | MA publication | 10 |
| 14/12/2021 | Certificate | 1 |
| 18/06/2025 | General Document | 1 |
| 18/06/2025 | Outgoing Correspondence | 2 |
| 18/06/2025 | General Document | 1 |
| 18/06/2025 | General Document | 1 |
| 18/06/2025 | Application Form | 4 |
| 18/06/2025 | General Document | 3 |
| 18/06/2025 | General Document | 113 |
| 18/06/2025 | Outgoing Correspondence | 1 |
| 18/06/2025 | Marketing authorization | 3 |
| 18/06/2025 | Publication | 1 |
| 18/06/2025 | FNET_DC_FRONTPAGE | 1 |