EMA — authorised 16 December 2019
- Marketing authorisation holder: A. Menarini Industrie Farmaceutiche Riunite s.r.l.
- Status: approved
🇪🇺 Baxdela in European Union
EMA authorised Baxdela on 16 December 2019
Marketing authorisations
EMA — authorised 16 December 2019
- Application: EMEA/H/C/004860
- Marketing authorisation holder: A. Menarini Industrie Farmaceutiche Riunite s.r.l.
- Local brand name: Quofenix
- Indication: Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Status: approved
Baxdela 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 Baxdela approved in European Union?
Yes. EMA authorised it on 16 December 2019; EMA authorised it on 16 December 2019.
Who is the marketing authorisation holder for Baxdela in European Union?
A. Menarini Industrie Farmaceutiche Riunite s.r.l. holds the EU marketing authorisation.