🇪🇺 Uptravi in European Union

EMA authorised Uptravi on 12 May 2016

Marketing authorisation

EMA — authorised 12 May 2016

  • Application: EMEA/H/C/003774
  • Marketing authorisation holder: Janssen Cilag International NV
  • Local brand name: Uptravi
  • Indication: Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. 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.
  • Status: approved

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Uptravi in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in European Union

Frequently asked questions

Is Uptravi approved in European Union?

Yes. EMA authorised it on 12 May 2016.

Who is the marketing authorisation holder for Uptravi in European Union?

Janssen Cilag International NV holds the EU marketing authorisation.