Bedaquilin (3) (Sirturo®) – Multidrug-resistant pulmonary tuberculosis, 5 to 11 years

1. Characteristics

Start date 01.04.2021
Resolution 16.09.2021
INN Bedaquilin
Brand name Sirturo®
Company Janssen-Cilag GmbH
G-BA procedure ID 2021-04-01-D-672
ATC code J04AK05
ICD-10 codes A15.0Tuberculous bronchiectasis, A15.1, A15.2, A15.3, A15.7Primary respiratory tuberculosis, A16.0, A16.1, A16.2, A16.7
DDD 86 mg O
Therapeutic area Infectious diseases ORPHAN
Reason for procedure New indication
Evidence transfer: Bedaquilin (2) (20.08.2020)
Regulatory status Conditional Approval

Indication (German)

SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Subgroup Indication Comparator
Kinder (im Alter von 5 Jahren bis unter 12 Jahren und mit einem Körpergewicht von mindestens 15 kg) mit multiresistenter pulmonaler Tuberkulose, wenn ein wirksames Behandlungsregime aufgrund von Resistenz oder Unverträglichkeit nicht anders als mit Bedaquilin (als Teil einer geeigneten Kombinationstherapie) zusammengestellt werden kann – (Orphan drug)

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Bedaquilin Sirturo® Multidrug-resistant pulmonary tuberculosis
Bedaquilin (2) Sirturo® Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years
Bedaquilin (3) Sirturo® Multidrug-resistant pulmonary tuberculosis, 5 to 11 years


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