Union européenne - français - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberculose, multirésistante - antimycobactériens - 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 et 5. la considération devrait être donnée à des recommandations officielles concernant l'utilisation appropriée des antibactériens.