European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.   - macitentan - hypertension, pulmonary - antihypertensives, - opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actelion pharmaceuticals uk ltd - macitentan - tablet - 10mg

Israel - English - Ministry of Health

j-c health care ltd - macitentan - film coated tablets - macitentan 10 mg - macitentan - opsumit ® is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression. disease progression included: death, initiation of intravenous (iv) or subcutaneous prostanoids or clinical worsening of pah (decreased 6-minute walk distance, worsened pah symptoms and need for additional pah treatment). opsumit also reduced hospitalization for pah.

Israel - English - Ministry of Health

j-c health care ltd - macitentan - film coated tablets - macitentan 10 mg - macitentan - opsumit ® is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression. disease progression included: death, initiation of intravenous (iv) or subcutaneous prostanoids or clinical worsening of pah (decreased 6-minute walk distance, worsened pah symptoms and need for additional pah treatment). opsumit also reduced hospitalization for pah.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - macitentan (micronized) - tablet, film coated - macitentan (micronized) 10.00mg

Canada - English - Health Canada

janssen inc - macitentan - tablet - 10mg - macitentan 10mg - vasodilating agents

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - macitentan 10 mg/1 tab - 10 mg/1 tab

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sudair pharma company, saudi arabia - macitentan - film-coated tablet - 10 mg,

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - macitentan - film coated tablets - macitentan 10 mg - macitentan - macitentan teva is an endothelin receptor antagonist (era) indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression. disease progression included: death, initiation of intravenous (iv) or subcutaneous prostanoids or clinical worsening of pah (decreased 6-minute walk distance, worsened pah symptoms and need for additional pah treatment).macitentan also reduced hospitalization for pah.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

acteltion pharmaceuticals ltd, switzerland - macitentan - film-coated tablet - 10 mg