EMA — authorised 23 April 2020
- Marketing authorisation holder: Shionogi B.V.
- Status: approved
🇪🇺 Fetroja in European Union
EMA authorised Fetroja on 23 April 2020
Marketing authorisations
EMA — authorised 23 April 2020
- Application: EMEA/H/C/004829
- Marketing authorisation holder: Shionogi B.V.
- Local brand name: Fetcroja
- Indication: Fetcroja is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Status: approved
Fetroja in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Fetroja approved in European Union?
Yes. EMA authorised it on 23 April 2020; EMA authorised it on 23 April 2020.
Who is the marketing authorisation holder for Fetroja in European Union?
Shionogi B.V. holds the EU marketing authorisation.