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)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
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)

Decision

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