CHMP positive recommendation to change the marketing authorisation of Sirturo (bedaquiline) in patients with pulmonary tuberculosis.- Jansssen- Cilag (J&J)
On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Sirturo (bedaquiline). The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.
The CHMP adopted a change to the existing indication as follows: Sirturo (bedaquiline) is indicated for use as part of an appropriate combination regimen in adults and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins