EMA — authorised 31 December 2009
- Application: EMEA/H/C/000864
- Marketing authorisation holder: Astellas Pharma Europe B. V.
- Local brand name: Vibativ
- Status: withdrawn
🇪🇺 Vibativ in European Union
EMA authorised Vibativ on 31 December 2009
Marketing authorisations
EMA — authorised 2 September 2011
- Application: EMEA/H/C/001240
- Marketing authorisation holder: Theravance Biopharma Ireland Umited
- Local brand name: Vibativ
- Indication: Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Status: withdrawn
Vibativ 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 Vibativ approved in European Union?
Yes. EMA authorised it on 31 December 2009; EMA authorised it on 2 September 2011.
Who is the marketing authorisation holder for Vibativ in European Union?
Astellas Pharma Europe B. V. holds the EU marketing authorisation.