We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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01 1ALFRED E TIEFENBACHER GmbH & Co KG
02 1ACTELION REGISTRATION LTD
03 1Acte Lion Registration Ltd
04 1Actelion Pharmaceuticals Ltd
05 1Devatis Gmbh
06 1Glenmark Arzneimittel Gmbh
07 1Janssen-Cilag Ag
08 3Janssen-Cilag International N.V.
09 4Janssen-Cilag International Nv
10 1Newbury Pharmaceuticals Ab
11 1Teva Gmbh
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01 1Macitantanum
02 10Macitentan
03 3Macitentan; Tadalafil
04 2Tadalafil; Macitentan
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01 1Antic-calc Tablet, Film Coated
02 1Dispersible Tablet
03 13Film Coated Tablet
04 1Macitentan 10Mg 30 Joined' Oral Use
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01 1Germany
02 1Italy
03 1Norway
04 3Spain
05 8Sweden
06 2Switzerland
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01 1Macitentan Devatis
02 1Macitentan Glenmark
03 1Macitentan Newbury
04 1Macitentan Teva
05 6Opsumit
06 4Yuvanci
07 1Yuvanci mg
08 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
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
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
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
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
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
Regulatory Info :
Registration Country : Norway
Brand Name : Opsumit
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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
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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