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01 1ALFRED E TIEFENBACHER GmbH & Co KG
02 1Olpha AS
03 1ACTELION REGISTRATION LTD
04 1Abacus Medicine A/S
05 2Accord Healthcare SLU
06 2Accord Healthcare Slu
07 1Actelion Pharmaceuticals Ltd
08 1Bioglan AB
09 1Clonmel Healthcare Limited
10 1Deva Holding A.?.
11 2Devatis Gmbh
12 1Genepharma SA
13 2Glenmark Arzneimittel Gmbh
14 4Janssen - Cilag International
15 1Janssen-Cilag Ag
16 3Janssen-Cilag International N.V.
17 1Janssen-Cilag International NV
18 10Janssen-Cilag International Nv
19 2Newbury Pharmaceuticals Ab
20 1Norameda Uab
21 1PharmaPath S.A.
22 1Pharmascience International Ltd
23 1Reddy Pharma Iberia Sa
24 1Reig Jofre Laboratory, Sa
25 1STADA Pharmaceuticals AG
26 1Sandoz A/S
27 1Stada Laboratory Sl
28 3Teva Gmbh
29 1medac pharma s.r.l
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01 1Macitantanum
02 40Macitentan
03 7Macitentan; Tadalafil
04 2Tadalafil; Macitentan
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01 3Dispersible Tablet
02 42Film 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 16Sweden
10 2Switzerland
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01 1 Masilva
02 1Cidevia
03 2Macitentan Accord
04 2Macitentan Accordpharma
05 1Macitentan Bioglan
06 1Macitentan Clonmel
07 1Macitentan Devatis
08 1Macitentan Dr. Reddy'S
09 1Macitentan Glenmark
10 1Macitentan Medac
11 1Macitentan Newbury
12 1Macitentan Norameda
13 1Macitentan Olpha
14 1Macitentan Pharmascience
15 1Macitentan Reig Jofre
16 1Macitentan Sandoz
17 2Macitentan Stada
18 2Macitentan Teva
19 1Macitentan "Devatis"
20 1Macitentan "Glenmark"
21 1Macitentan "Newbury"
22 1Macitentan "Teva"
23 11Opsumit
24 2Opsumit®
25 1Sozation
26 8Yuvanci
27 1Yuvanci mg
28 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
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Olpha
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 02-10-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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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 : Approved
Registration Country : Sweden
Brand Name : Macitentan Accord
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 24-09-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Accordpharma
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 24-09-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Bioglan
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 17-12-2025
Application Number : 2.02E+13
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
