EMEA-002755-PIP01-19

Table of contents

Key facts

Active substance
Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
Therapeutic area
Infectious diseases
Decision number
P/0486/2020
PIP number
EMEA-002755-PIP01-19
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
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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