🇪🇺 Vantobra in European Union

EMA authorised Vantobra on 18 March 2015

Marketing authorisations

EMA — authorised 18 March 2015

  • Application: EMEA/H/C/002633
  • Marketing authorisation holder: Pari Pharma GmbH
  • Local brand name: Vantobra
  • Indication: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: withdrawn

Read official source →

EMA — authorised 19 March 2015

  • Status: approved

Vantobra 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 Vantobra approved in European Union?

Yes. EMA authorised it on 18 March 2015; EMA authorised it on 19 March 2015.

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

Pari Pharma GmbH holds the EU marketing authorisation.