EMEA-000912-PIP01-10-M06
Key facts
| Invented name |
Sirturo
|
| Active substance |
bedaquiline fumarate
|
| Therapeutic area |
Infectious diseases
|
| Decision number |
P/0470/2022
|
| PIP number |
EMEA-000912-PIP01-10-M06
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of multi-drug-resistant tuberculosis
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Janssen-Cilag International NV
Tel. +32 1460 2111 E-mail: contact@janssen-emea.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|