Countries in which the medicines have been registered+ | Countries in which regulatory dossiers have been filed | |
Bedaquiline | Armenia, China, EU,§ Hong Kong, India, Moldova, New Zealand, Peru, Philippines, Russia, South Africa, South Korea, Taiwan, Thailand, Turkey, Turkmenistan, USA, Uzbekistan | Bangladesh, Brazil, Burundi,ƒ Cameroon,ƒ Ethiopia,ƒ Ghana,ƒ Indonesia, Japan, Kenya,ƒ Mexico, Nigeria,ƒ Rwanda,ƒ Tanzania,ƒ Uganda,ƒ Vietnam |
Delamanid | EU,§ Hong Kong, India, Japan, Philippines, South Korea, Turkey | China, Indonesia, Peru, South Africa |
#: data are up to date as of October 2017. ¶: the countries in italics are multidrug-resistant tuberculosis high burden countries. +: in Colombia, bedaquiline is in the country's list of “Medicamentos Vitales No Disponibles”, as an interim alternative for local registration; and in Macau, bedaquiline is considered to be registered in the country, via import licensing, although no formal regulatory approval was pursued by Jannsen. §: number of countries included in European Medicines Agency approval is 31. ƒ: countries are part of the World Health Organization collaborative registration procedure for stringent regulatory authority-approved products.