Key facts

Active Substance
N-(3-cyano-4-fluorophenyl)-1-methyl-4-[[(2S)-1,1,1-trifluoro-2-propanyl]sulfamoyl]-1H-pyrrole-2- carboxamide (JNJ-56136379)
Therapeutic area
Infectious diseases
Decision number
P/0418/2020
PIP number
EMEA-002693-PIP01-19
Pharmaceutical form(s)
  • Tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of chronic viral hepatitis B
Route(s) of administration
Oral use
Contact for public enquiries

Janssen-Cilag International NV

Tel. +32 1460 2111

E-mail: contact@janssen-emea.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

P/0418/2020 : EMA decision of 22 October 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver...(EMEA-002693-PIP01-19)

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