EMEA-002755-PIP01-19-M02 - paediatric investigation plan

Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
PIPHuman

Key facts

Active Substance
Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
Therapeutic area
Infectious diseases
Decision number
P/0523/2023
PIP number
EMEA-002755-PIP01-19-M02
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Prevention of lower respiratory tract infection caused by respiratory syncytial virus
Route(s) of administration
Intramuscular use
Contact for public enquiries

Merck Sharp & Dohme (Europe), Inc.

Tel. +33 180464738
Email: pip.information@merck.com

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

Decision

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