EMEA-001868-PIP02-16 - paediatric investigation plan

5-(4-cyclopropyl-1H-imidazol-1-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridi-2-yl)-4-methylbenzamide
PIPHuman

Key facts

Active Substance
5-(4-cyclopropyl-1H-imidazol-1-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridi-2-yl)-4-methylbenzamide
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0072/2017
PIP number
EMEA-001868-PIP02-16
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Treatment of alcoholic hepatitis
Route(s) of administration
Oral use
Contact for public enquiries

Gilead Sciences International Ltd.

United Kingdom
E-mail: regulatory.pip@gilead.com
Tel.: +44 1223897300
Fax: +44 (0)1223897284

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

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