🇪🇺 Tobramycin Powder in European Union

EMA authorised Tobramycin Powder on 20 July 2011

Marketing authorisation

EMA — authorised 20 July 2011

  • Application: EMEA/H/C/002155
  • Marketing authorisation holder: Viatris Healthcare Limited
  • Local brand name: Tobi Podhaler
  • Indication: Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

Read official source →

Tobramycin Powder in other countries

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

Frequently asked questions

Is Tobramycin Powder approved in European Union?

Yes. EMA authorised it on 20 July 2011.

Who is the marketing authorisation holder for Tobramycin Powder in European Union?

Viatris Healthcare Limited holds the EU marketing authorisation.