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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 2Devatis Gmbh
09 2Glenmark Arzneimittel Gmbh
10 4Janssen - Cilag International
11 1Janssen-Cilag Ag
12 3Janssen-Cilag International N.V.
13 1Janssen-Cilag International NV
14 10Janssen-Cilag International Nv
15 2Newbury 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 3Teva Gmbh
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01 1Macitantanum
02 32Macitentan
03 7Macitentan; Tadalafil
04 2Tadalafil; Macitentan
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01 3Dispersible Tablet
02 34Film Coated Tablet
03 4Film-Coated Tablet
04 1Macitentan 10Mg 30 Joined' Oral Use
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01 8Denmark
02 5Estonia
03 1Germany
04 1Italy
05 3Malta
06 3Moldova
07 2Norway
08 9Spain
09 8Sweden
10 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 1Macitentan "Devatis"
16 1Macitentan "Glenmark"
17 1Macitentan "Newbury"
18 1Macitentan "Teva"
19 11Opsumit
20 2Opsumit®
21 8Yuvanci
22 1Yuvanci mg
23 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 : Marketed
Registration Country : Norway
Brand Name : Opsumit
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Macitentan Accord
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 17-11-2025
Application Number : 1251970004
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Macitentan Accordpharma
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 18-11-2025
Application Number : 1251971004
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Macitentan Clonmel
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2025-07-04
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

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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 :
Registration Country : Moldova
Brand Name : Masilva
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date : 26-08-2024
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Macitentan \"Devatis\"
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 29-07-2025
Application Number : 28107146124
Regulatory Info : Prescription
Registration Country : Denmark

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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
