🇪🇺 CHF5259 in European Union

EMA authorised CHF5259 on 28 September 2012

Marketing authorisations

EMA — authorised 28 September 2012

  • Application: EMEA/H/C/002690
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Tovanor Breezhaler
  • Indication: Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
  • Status: approved

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EMA — authorised 28 September 2012

  • Application: EMEA/H/C/002691
  • Marketing authorisation holder: Novartis Europharm Ltd
  • Local brand name: Enurev Breezhaler
  • Indication: Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
  • Status: approved

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Frequently asked questions

Is CHF5259 approved in European Union?

Yes. EMA authorised it on 28 September 2012; EMA authorised it on 28 September 2012.

Who is the marketing authorisation holder for CHF5259 in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.