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01 1ALFRED E TIEFENBACHER GmbH & Co KG
02 1ACTELION REGISTRATION LTD
03 1Abacus Medicine A/S
04 2Accord Healthcare Slu
05 1Actelion Pharmaceuticals Ltd
06 1Clonmel Healthcare Limited
07 1Deva Holding A.?.
08 1Devatis Gmbh
09 1Glenmark Arzneimittel Gmbh
10 4Janssen - Cilag International
11 1Janssen-Cilag Ag
12 3Janssen-Cilag International N.V.
13 1Janssen-Cilag International NV
14 6Janssen-Cilag International Nv
15 1Newbury Pharmaceuticals Ab
16 1Norameda Uab
17 1PharmaPath S.A.
18 1Pharmascience International Ltd
19 1Reddy Pharma Iberia Sa
20 1Reig Jofre Laboratory, Sa
21 1Stada Laboratory Sl
22 2Teva Gmbh
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01 1Macitantanum
02 26Macitentan
03 5Macitentan; Tadalafil
04 2Tadalafil; Macitentan
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01 2Dispersible Tablet
02 27Film Coated Tablet
03 4Film-Coated Tablet
04 1Macitentan 10Mg 30 Joined' Oral Use
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01 5Estonia
02 1Germany
03 1Italy
04 3Malta
05 3Moldova
06 2Norway
07 9Spain
08 8Sweden
09 2Switzerland
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01 1 Masilva
02 1Cidevia
03 1Macitentan Accord
04 1Macitentan Accordpharma
05 1Macitentan Clonmel
06 1Macitentan Devatis
07 1Macitentan Dr. Reddy'S
08 1Macitentan Glenmark
09 1Macitentan Newbury
10 1Macitentan Norameda
11 1Macitentan Pharmascience
12 1Macitentan Reig Jofre
13 1Macitentan Stada
14 2Macitentan Teva
15 9Opsumit
16 2Opsumit®
17 6Yuvanci
18 1Yuvanci mg
19 1Blank
Regulatory Info : EU Dossier Readiness-Q4 2023
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q4 2023
Registration Country : Germany
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Devatis
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 03/07/2025
Application Number : 20240314000073
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Glenmark
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 24/03/2025
Application Number : 20231221000157
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Opsumit
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 20/12/2013
Application Number : 20121211000079
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Opsumit
Dosage Form : Dispersible Tablet
Dosage Strength : 2.5mg
Packaging :
Approval Date : 04/10/2024
Application Number : 20231009000171
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Yuvanci
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg;20mg
Packaging :
Approval Date : 27/09/2024
Application Number : 20230623000024
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info :
Registration Country : Italy
Brand Name : Opsumit
Dosage Form : Macitentan 10Mg 30 Joined' Oral Use
Dosage Strength : 30 cpr riv 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Opsumit
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 06/02/2014
Application Number : 61863
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Teva
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 09/05/2025
Application Number : 20231228000105
Regulatory Info : Approved
Registration Country : Sweden

Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Newbury
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 27/03/2025
Application Number : 20231221000010
Regulatory Info : Approved
Registration Country : Sweden

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