Key facts

Invented name
  • Humenza
  • Humenza
Active Substance
Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Therapeutic area
Vaccines
Decision number
P/0022/2019
PIP number
EMEA-000669-PIP01-09-M02
Pharmaceutical form(s)
Suspension and emulsion for injection
Condition(s) / indication(s)
Prevention of influenza
Route(s) of administration
Intramuscular use
Contact for public enquiries

Sanofi Pasteur SA

E-mail: Piplan@sanofipasteur.com
Country: France
Phone: +33 437375038

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000669-PIP01-09-M02
Compliance opinion date
Compliance outcome
Positive

Decision

P/0022/2019: EMA decision of 4 January 2019 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigen equivalent to A/California/7/2009(H1N1)-like strain (A/California/7/2009 (

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