EMEA-002109-PIP01-16 - paediatric investigation plan

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)

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
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2018
• Compliance check done:
  No

Decision

P/0023/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydr...

Reference Number: EMA/28678/2018