EMEA-001411-PIP01-12-M04
Key facts
Invented name |
Harvoni
|
Active substance |
|
Therapeutic area |
Infectious diseases
|
Decision number |
P/0063/2017
|
PIP number |
EMEA-001411-PIP01-12-M04
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
Treatment of chronic hepatitis C
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Gilead Sciences International Ltd.
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-001411-PIP01-12-M04
|
Compliance opinion date |
26/04/2019
|
Compliance outcome |
positive
|