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macitentan (Opsumit®)

 

Following a full submission

AWMSG advice

Status: Recommended

Macitentan (Opsumit®) is recommended as an option for use within NHS Wales as monotherapy or in combination for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme is utilised.

 Final Recommendation: macitentan (Opsumit) 711 (PDF, 274Kb)
 Appraisal Report: macitentan (Opsumit) 711 (PDF, 235Kb)

Medicine details

Medicine name macitentan (Opsumit®)
Formulation 10 mg film-coated tablet
Reference number 711
Indication

Long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, as a monotherapy or in combination

Company Actelion Pharmaceuticals UK Ltd
BNF chapter Cardiovascular system
Submission type Full
Status Recommended
Advice number 4215
NMG meeting date 04/11/2015
AWMSG meeting date 09/12/2015
Ratification by Welsh Government 06/01/2016
Date of issue 11/01/2016
Date of last review 13/06/2019
Commercial arrangement WPAS
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