Darunavir
Key facts
| Invented name |
Prezista
|
| Active substance |
darunavir
|
| Therapeutic area |
Infectious diseases
|
| Decision number |
P/138/2010
|
| PIP number |
Darunavir
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of human immunodeficiency virus (HIV-1) infection
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Janssen-Cilag International NV
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000038-PIP01-07-M03
|
| Compliance opinion date |
13/12/2011
|
| Compliance outcome |
positive
|