EMEA-001113-PIP01-10-M06
Key facts
Invented name |
Deltyba
|
Active substance |
Delamanid
|
Therapeutic area |
Infectious diseases
|
Decision number |
P/0271/2019
|
PIP number |
EMEA-001113-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 |
Otsuka Pharmaceutical Development & Commercialisation Europe GmbH
Tel. +49 6995 5044321 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-001113-PIP01-10-M06
|
Compliance opinion date |
24/07/2020
|
Compliance outcome |
positive
|