Sirturo - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

bedaquiline

Opinion

On 24 July 2025 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. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

The CHMP adopted an extension to an existing indication to include treatment of children from 2 years of age weighing at least 7 kg.

The full indication for Sirturo will therefore be as follows:¹

Sirturo is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (52 years to less than 18 years of age and weighing at least 157 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. 
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Sirturo (EMAVR0000249065)

Adopted Reference Number: EMADOC-1700519818-2301684

Key facts

• Name of medicine:
  Sirturo
• EMA product number:
  EMEA/H/C/002614
• Active substance:
  bedaquiline fumarate
• International non-proprietary name (INN) or common name:
  bedaquiline
• Therapeutic area (MeSH):
  Tuberculosis, Multidrug-Resistant
• Anatomical therapeutical chemical (ATC) code:
  J04AK05
• Marketing authorisation holder:
  Janssen-Cilag International N.V.
• Date of opinion:
  24/07/2025
• Status:
  Positive