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Opsumit

10 milligram(s) Film-coated tablet

Janssen Pharmaceutica N.V.EU/1/13/893/001-003

Main Information

Trade NameOpsumit
Active SubstancesMacitentan
Strength10 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderJanssen Pharmaceutica N.V.
Licence NumberEU/1/13/893/001-003

Group Information

ATC CodeC02KX Other antihypertensives
C02KX04 macitentan

Status

Authorised/WithdrawnAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

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