EMEA-000016-PIP01-07-M08
Key facts
| Invented name |
Xydalba
|
| Active substance |
dalbavancin hydrochloride
|
| Therapeutic area |
Infectious diseases
|
| Decision number |
P/0522/2021
|
| PIP number |
EMEA-000016-PIP01-07-M08
|
| Pharmaceutical form(s) |
Powder for concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of acute bacterial skin and skin structure infections
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Allergan Pharmaceuticals International Limited
E-mail: ml-eu_reg_affairs@allergan.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|