Patent details

301308 Product Name: Een combinatie van (a) macitentan of een farmaceutisch aanvaardbaar zout daarvan en (b) tadalafil of een farmaceutisch aanvaardbaar zout daarvan

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Basic Information

Publication number:
301308
Type:
Certificate
SPC Type:
Medical
Basic Patent Number:
EP2059246
Status:
SPC granted but not yet in force
Application number:
301308
Procedural language:
Dutch
First Applicant Residence Country:
Switzerland (CH)

Marketing Authorization

Marketing Authorization Number:
EU/1/24/1859
Marketing Authorization Type:
EEA
Marketing Authorization Date:
30/09/2024
Marketing Authorization Country:
European Union (EU)

Dates

Filing date:
18/12/2024
First Marketing Authorization date:
30/09/2024
Grant date:
30/12/2024
Activation date:
Lapsed By Non Payment Annual Fee Date:
Renunciation Date:
NullificationDate:
Registration date:
18/12/2024
SPC/SPC Extension Expiration Date:
27/08/2032
Lapsed By Expiration Date:
Withdrawal date:
Revocation Date:
Invalidity Date:
Withdrawal Market Authorization Date:
Refusal Date:

Applicant/holder

From:
18/12/2024
 
 

 

Name:
Actelion Pharmaceuticals Ltd.
Address:
Gewerbestrasse 16, 4123, ALLSCHWIL, Switzerland (CH)

Agent

Name:
ir. H.A. Witmans c.s.
From:
18/12/2024
Address:
V.O. Postbus 87930, 2508 DH, Den Haag, Netherlands (NL)
To:

Publication

Bulletin

1

Bulletin Heading:
SPC
Journal edition number:
01/25
Publication date:
22/01/2025
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

2

Bulletin Heading:
SPC
Journal edition number:
52/24
Publication date:
08/01/2025
Description:
Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)

Annual Fee

Annual Fee(s) Due Date:
31/08/2027
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
30/12/2024 Outgoing Correspondence Decision grant 1 PDF /9/5/5/1/7/0801071559/docs/301308_0_637373l504a.pdf
30/12/2024 Certificate Certificate 1 PDF /9/5/5/1/7/0801071559/docs/301308_1_spcmedcertificate20241230115659518.pdf
20/12/2024 Outgoing Correspondence Confirmation receipt request 2 PDF /9/5/5/1/7/0801071559/docs/301308_11_636665l174.pdf
18/12/2024 Application Form First filed application form 3 PDF /9/5/5/1/7/0801071559/docs/301308_2_applicationform20241218041236150.pdf
18/12/2024 SPC Documents Annex SPC 4 PDF /9/5/5/1/7/0801071559/docs/301308_3_supplprotectioncertificate20241218041236279.pdf
18/12/2024 SPC Documents Annex SPC 3 PDF /9/5/5/1/7/0801071559/docs/301308_4_supplprotectioncertificate20241218041236291.pdf
18/12/2024 SPC Documents Marketing Authorization SPC 3 PDF /9/5/5/1/7/0801071559/docs/301308_5_supplprotectioncertificate20241218041236208.pdf
18/12/2024 SPC Documents Summary of the characteristics of the product 21 PDF /9/5/5/1/7/0801071559/docs/301308_6_supplprotectioncertificate20241218041236228.pdf
18/12/2024 SPC Documents Annex SPC 20 PDF /9/5/5/1/7/0801071559/docs/301308_7_supplprotectioncertificate20241218041236245.pdf
18/12/2024 SPC Documents Annex SPC 2 PDF /9/5/5/1/7/0801071559/docs/301308_8_supplprotectioncertificate20241218041236236.pdf
18/12/2024 SPC Documents Annex SPC 3 PDF /9/5/5/1/7/0801071559/docs/301308_9_supplprotectioncertificate20241218041236253.pdf
18/12/2024 SPC Documents Accompanying letter SPC 1 PDF /9/5/5/1/7/0801071559/docs/301308_10_supplprotectioncertificate20241218041236191.pdf