Geneva – The World Health Organization (WHO) has prequalified a new formulation of a medicine critical for treatment of tuberculosis (TB) in children.

The fixed dose combination (FDC) tablet, manufactured by Macleods Pharmaceuticals Limited, contains two medicines in one pill – 75 mg of rifampicin + 50 mg isoniazid.  Child-friendly TB fixed-dose combinations were developed with support from Unitaid through the STEP-TB project spearheaded by the Global Alliance for TB Drug Development.

WHO’s inclusion of the medicine in its Prequalification list means that the product has been found to meet international standards of quality, safety and efficacy, and will rapidly expand access to effective TB treatment for children globally. It is available for procurement through the Global Drug Facility, which supports the procurement of TB medicines for United Nations programmes, international procurement agencies and national procurement entities.

Since 2006, Unitaid has provided support to WHO’s Prequalification Programme (PQ) and is its largest funder. WHO PQ activities are central to Unitaid’s strategy in assuring the highest quality medicines and diagnostics are on the market for procurement by donor organizations and country governments.

Find out more:

“WHO Prequalifies key treatment for children with TB” – WHO website