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
|