EMEA-001838-PIP01-15-M02

Key facts

Active substance
3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678)
Therapeutic area
Infectious diseases
Decision number
P/0081/2019
PIP number
EMEA-001838-PIP01-15-M02
Pharmaceutical form(s)
Oral solution
Condition(s) / indication(s)
Treatment of lower respiratory tract disease caused by human respiratory syncytial virus (RSV)
Route(s) of administration
Oral use
Contact for public enquiries
Janssen-Cilag International NV

Tel.: +32 14602111
E-mail: contact@janssen-emea.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

How useful was this page?

Add your rating