EMEA-002172-PIP02-17-M01

Key facts

Active substance
Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
Therapeutic area
  • Infectious diseases
  • Vaccines
Decision number
P/0197/2020
PIP number
EMEA-002172-PIP02-17-M01
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Prevention of lower respiratory tract disease caused by respiratory syncytial virus
Route(s) of administration
Intramuscular use
Contact for public enquiries
Janssen-Cilag International NV

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

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

Decision

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