EMEA-002693-PIP01-19

Table of contents

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)
  • Tablets
  • 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

E-mail: contact@janssen-emea.com
Tel. +32 1460 2111

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

Decision

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