EMEA-002307-PIP01-17-M02

Table of contents

Key facts

Invented name
Zabdeno
Active substance
Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
Therapeutic area
  • Infectious diseases
  • Vaccines
Decision number
P/0307/2021
PIP number
EMEA-002307-PIP01-17-M02
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Prevention of Ebola virus disease
Route(s) of administration
Intramuscular use
Contact for public enquiries
Janssen Cilag International NV

Tel. +3214602111
E-mail: contact@Janssen-emea.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-002307-PIP01-17-M02
Compliance opinion date
24/06/2022
Compliance outcome
positive

Decision

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