This site uses cookies to give you a better browsing experience, you can find out more about the cookies we use here.
Incure
РУССКИЙ ENGLISH


INCURE has submitted applications for inclusion of 5 additional formulations into EML

Incure has submitted 5 applications for the inclusion of 5 different additional formulation into EML and EMLc.

Injectable Rifampicin, injectable isoniazid, injectable Ethambutol, injectable PAS are proposed for the inclusion into core list of EML and EMLc, Isoniazid syrup 100 mg/ml is proposed for the inclusion into core list of EMLc.

The EML and EMLc already contain preparations of oral forms of drugs listed above. This application proposes IV forms for the core list of WHO Model List of Essential Medicines, as a lifesaving medicines for the following categories:  

  1. Patients with severe forms of tuberculosis with poor outcomes, requiring intensive treatment (Miliary TB, caseous pneumonia, TB meningitis, TB sepsis, TB pericarditis). 
  2. Patients with acute or chronical gastrointestinal diseases, or patients with reduced absorption rates of oral forms (malabsorption in PLWH).
  3. Patients with severe comorbidities: HIV/TB, diabetes/TB, etc.
  4. Patients that are unable (unconscious patients in ICU or in coma) or unwilling to take drugs in periods of depression or due to acute manifestations of altered mental condition

Target regimen profiles for TB treatment: candidates: rifampicin-susceptible, rifampicin resistant and pan-TB treatment regimens, published in 2016 by WHO state that IV formulations should be reserved for cases of severe forms of disease, however they are not available in most of the countries. 

Isoniazid syrup 100 mg/ml summary of proposal states that  EML and EMLc already contain Isoniazid dispersible tablets and oral liquid 50 mg / 5 mL, however oral liquid 50 mg / 5 ml is not available in many countries in existing concentration. Dispersible tablets cannot provide exact dose of Isoniazid, considering weight of children, because they shouldn’t be divided according to instructions for use.

To support the application and give public comments, please visit WHO website: 

https://www.who.int/selection_medicines/committees/expert/22/eml22applications/en/

24/01/2019