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OPSUMIT

10 Milligram Film Coated Tablet

Actelion Registration LtdEU/1/13/893/001-003

Main Information

Trade NameOPSUMIT
Active SubstancesMACITENTAN
Strength10 Milligram
Dosage FormFilm Coated Tablet
Licence HolderActelion Registration Ltd
Licence NumberEU/1/13/893/001-003

Group Information

ATC CodeC02KX04 Antihypertensives for pulmonary arterial hypertension

Status

Authorised/WithdrawnAuthorised
Licence Issued20/12/2013
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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

Educational Materials - HCP

Checklist for prescribers
HCP Brochure

Educational Materials - Patient

Patient Card
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