Formulary Decisions
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Indication
Initial treatment of tuberculosis according to World Health Organisation (WHO) guidelines.
Therapeutic Area
Infections
Status Description
Routinely available in line with local or regional guidance
Formulation
Film-coated tablets
Comments
The ERFC reviewed the submission, noting that the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication, with SMC not recommended advice SMC876/13. The ERFC accepted a FAF4 application as the advice is > 10 years old. The ERFC agreed to classify FAF4 Isoniazid/Rifampicin/Pyrazinamide/Ethambutol: Rimstar/Voractiv as Routinely available in line with local or regional guidance. Included on the ERF for Specialist Use Only.
Link to Advice
Advice Published
13/05/2013
SMC Submission Type
Non submission
SMC Status
Not recommended