EMEA-002109-PIP01-16
Key facts
| Active substance |
1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4-yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic acid (GS-0976)
|
| Therapeutic area |
Gastroentology-Hepatology
|
| Decision number |
P/0023/2018
|
| PIP number |
EMEA-002109-PIP01-16
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of non-alcoholic steatohepatitis (NASH)
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Gilead Sciences International Ltd.
Tel. +44 1223897300
E-mail: regulatory.pip@gilead.com |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|