Deltyba (delamanid)
- Region
- 🇪🇺 EU
- Active substance
- delamanid
- Company
- Otsuka Novel Products GmbH
- Status
- Authorised
- Therapeutic area
- Tuberculosis, Multidrug-Resistant
- CHMP opinion
- Thu 21 Nov 2013
- EU approval
- Sun 27 Apr 2014
- Application
- EMEA/H/C/002552
- ATC
- J04AK06
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.