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macitentan (Opsumit®)
Reference No. 711
Publication date:
11/01/2016
Appraisal information
macitentan (Opsumit®) 10 mg film-coated tablet
Company:
Actelion Pharmaceuticals UK Ltd
BNF category:
Cardiovascular system
NMG meeting date:
04/11/2015
AWMSG meeting date:
09/12/2015
Submission Type:
Full Submission
Status:
Recommended
Advice No:
4215
Ministerial ratification:
06/01/2016
Current Progress
Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification
AWMSG advice
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 Appraisal Recommendation (FAR)
Download
macitentan (Opsumit) 711 FAR
AWMSG Secretariat Appraisal Report (ASAR)
Download
macitentan (Opsumit) 711 ASAR
Clinical Expert (CE) Summary
Download
macitentan (Opsumit) 711 CE Summary
