EMEA-001784-PIP01-15-M01

Key facts

Active substance
Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897)
Therapeutic area
Infectious diseases
Decision number
P/0305/2019
PIP number
EMEA-001784-PIP01-15-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
MedImmune Limited
United States
Tel. +1 5828 36181
E-mail: paediatrics@medimmune.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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