EMA
approval
· 2024-10-25
EMA Authorised: Tracleer (bosentan (as monohydrate)) — Janssen-Cilag International N.V.
Summary
The European Medicines Agency authorised Tracleer (bosentan) for systemic sclerosis and for pulmonary arterial hypertension.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Scleroderma, Systemic;Hypertension, Pulmonary. MAH: Janssen-Cilag International N.V.. Decision date: 23/10/2024