Key facts

Invented name
Influvac Tetra
Active Substance
Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
Therapeutic area
Vaccines
Decision number
P/0211/2018
PIP number
EMEA-001782-PIP01-15-M03
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Prevention of influenza infection
Route(s) of administration
Intramuscular use
Contact for public enquiries

Abbott Biologicals B.V.

Tel. +41 6148 70374
Email: hind.ounis@abbott.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001782-PIP01-15-M03
Compliance opinion date
Compliance outcome
Positive

Decision

P/0211/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata linea

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