EMA — authorised 22 November 2013
- Status: approved
🇪🇺 Deltyba in European Union
EMA authorised Deltyba on 22 November 2013
Marketing authorisations
EMA — authorised 27 April 2014
- Application: EMEA/H/C/002552
- Marketing authorisation holder: Otsuka Novel Products GmbH
- Local brand name: Deltyba
- Indication: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Pathway: orphan
- Status: approved
Deltyba 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 Deltyba approved in European Union?
Yes. EMA authorised it on 22 November 2013; EMA authorised it on 27 April 2014.
Who is the marketing authorisation holder for Deltyba in European Union?
Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.