Patent details
300672 Product Name: Macitentan, desgewenst in de vorm van een farmaceutisch aanvaardbaar zout
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Basic Information
- Publication number:
- 300672
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP1345920
- Status:
- SPC in force
- Application number:
- 300672
- Procedural language:
- Dutch
- First Applicant Residence Country:
Paediatric Extension
- SPC Extension Filing Date:
- 29/11/2024
- SPC Extension Agent/Owner Name:
- ir. H.A. Witmans c.s. , Actelion Pharmaceuticals Ltd.
- SPC Extension Status:
- Extension Granted
- SPC Extension Grant Date:
- 05/12/2024
- SPC Extension Request Refusal Date:
- SPC Extension Revocation Date:
Marketing Authorization
- Marketing Authorization Number:
- EU/1/13/893/001-003
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 20/12/2013
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 12/06/2014
- First Marketing Authorization date:
- 20/12/2013
- Grant date:
- 11/10/2016
- Activation date:
- 04/12/2021
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 05/11/2015
- SPC/SPC Extension Expiration Date:
- 03/06/2027
- Lapsed By Expiration Date:
- Withdrawal date:
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 12/06/2014
- Name:
- Actelion Pharmaceuticals Ltd.
- Address:
- Gewerbestrasse 16, 4123, Allschwil, Switzerland (CH)
Agent
1
- Name:
- ir. B.Ch. Ledeboer c.s
- From:
- 28/07/2025
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
2
- Name:
- ir. H.A. Witmans c.s.
- From:
- 12/06/2014
- Address:
- V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
- To:
- 28/07/2025
Publication
Bulletin
1
- Bulletin Heading:
- SPC
- Journal edition number:
- 50/24
- Publication date:
- 11/12/2024
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 49/24
- Publication date:
- 04/12/2024
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
- Bulletin Heading:
- SPC
- Journal edition number:
- 49/21
- Publication date:
- 08/12/2021
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
- Bulletin Heading:
- SPC
- Journal edition number:
- 41/16
- Publication date:
- 12/10/2016
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
5
- Bulletin Heading:
- SPC
- Journal edition number:
- 46/15
- Publication date:
- 11/11/2015
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
6
- Bulletin Heading:
- SPC
- Journal edition number:
- 2014/26
- Publication date:
- 25/06/2014
- 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:
- 02/12/2025
- Last Annual Fee Paid Number:
- 25
- Last Annual Fee Paid Amount:
- 2400 Euro
- Payer:
- Arnold & Siedsma BV
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 05/12/2024 | Outgoing Correspondence | Decision extension duration | 1 | /2/7/6/0/0/0400300672/docs/300672_18_634400l504c.pdf | ||
| 05/12/2024 | Certificate | Certificate | 1 | /2/7/6/0/0/0400300672/docs/300672_19_spcxcertificate20241205114617315.pdf | ||
| 02/12/2024 | Outgoing Correspondence | Confirmation receipt request for extension | 2 | /2/7/6/0/0/0400300672/docs/300672_10_633711l505.pdf | ||
| 29/11/2024 | SPC Documents | Annex SPC | 1 | /2/7/6/0/0/0400300672/docs/300672_11_supplprotectioncertificate20241202103136737.pdf | ||
| 29/11/2024 | Application Form | First filed application form | 3 | /2/7/6/0/0/0400300672/docs/300672_12_applicationform20241202103136472.pdf | ||
| 29/11/2024 | SPC Documents | Marketing Authorization SPC | 3 | /2/7/6/0/0/0400300672/docs/300672_13_supplprotectioncertificate20241202103136758.pdf | ||
| 29/11/2024 | SPC Documents | Annex SPC | 25 | /2/7/6/0/0/0400300672/docs/300672_14_supplprotectioncertificate20241202103136791.pdf | ||
| 29/11/2024 | SPC Documents | Annex SPC | 2 | /2/7/6/0/0/0400300672/docs/300672_15_supplprotectioncertificate20241202103136784.pdf | ||
| 29/11/2024 | SPC Documents | Summary of the characteristics of the product | 37 | /2/7/6/0/0/0400300672/docs/300672_16_supplprotectioncertificate20241202103136766.pdf | ||
| 29/11/2024 | SPC Documents | Annex SPC | 1 | /2/7/6/0/0/0400300672/docs/300672_17_supplprotectioncertificate20241202103136745.pdf | ||
| 11/10/2016 | SPC Documents | Certificate SPC | 1 | /2/7/6/0/0/0400300672/docs/300672_2_supplprotectioncertificate20161011025849987.pdf | ||
| 11/10/2016 | Outgoing Correspondence | Decision grant | 1 | /2/7/6/0/0/0400300672/docs/300672_3_outgoingcorrespondence20161011025849858.pdf | ||
| 16/06/2014 | Outgoing Correspondence | Outgoing Letter | 1 | /2/7/6/0/0/0400300672/docs/300672_9_outgoingcorrespondence20140616.pdf | ||
| 12/06/2014 | SPC Documents | Annex SPC | 3 | /2/7/6/0/0/0400300672/docs/300672_0_supplprotectioncertificate20201026112637009.pdf | ||
| 12/06/2014 | Application Form | First filed application form | 3 | /2/7/6/0/0/0400300672/docs/300672_1_applicationform20140613.pdf | ||
| 12/06/2014 | SPC Documents | Annex SPC | 17 | /2/7/6/0/0/0400300672/docs/300672_4_supplprotectioncertificate20201026112637096.pdf | ||
| 12/06/2014 | SPC Documents | Annex SPC | 3 | /2/7/6/0/0/0400300672/docs/300672_5_supplprotectioncertificate20201026105647638.pdf | ||
| 12/06/2014 | SPC Documents | Summary of the characteristics of the product | 14 | /2/7/6/0/0/0400300672/docs/300672_6_supplprotectioncertificate20201026112636917.pdf | ||
| 12/06/2014 | SPC Documents | Marketing Authorization SPC | 3 | /2/7/6/0/0/0400300672/docs/300672_7_supplprotectioncertificate20201026110141646.pdf | ||
| 12/06/2014 | SPC Documents | Annex SPC | 3 | /2/7/6/0/0/0400300672/docs/300672_8_supplprotectioncertificate20201026111217660.pdf |