EMEA-001784-PIP01-15-M03

Table of contents

Key facts

Active substance
Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897)
Therapeutic area
  • Infectious diseases
  • Vaccines
Decision number
P/0296/2021
PIP number
EMEA-001784-PIP01-15-M03
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
AstraZeneca AB

Tel. +46 855259283
E-mail: paediatrics@astrazeneca.com

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

Decision

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