EMEA-001276-PIP01-12-M02
Key facts
| Invented name |
Sovaldi
|
| Active substance |
Sofosbuvir
|
| Therapeutic area |
Infectious diseases
|
| Decision number |
P/0172/2018
|
| PIP number |
EMEA-001276-PIP01-12-M02
|
| 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
E-mail: regulatory.pip@gilead.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001276-PIP01-12-M02
|
| Compliance opinion date |
26/04/2019
|
| Compliance outcome |
positive
|