🇪🇺 Ohtuvayre in European Union

Ohtuvayre (ENSIFENTRINE) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/006742
  • Marketing authorisation holder: Verona Pharma Ireland Limited
  • Local brand name: Ohtuvayre
  • Indication: Maintenance treatment in symptomatic adult patients with chronic obstructive pulmonary disease (COPD).
  • Status: withdrawn

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Ohtuvayre in other countries

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

Other Respiratory approved in European Union

Frequently asked questions

Is Ohtuvayre approved in European Union?

Yes. EMA has authorised it.

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

Verona Pharma Ireland Limited holds the EU marketing authorisation.