Key facts

Invented name
  • Foclivia and associated names
  • Foclivia
Active Substance
Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Therapeutic area
Vaccines
Decision number
P/0188/2020
PIP number
EMEA-001830-PIP01-15-M02
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Prevention of influenza infection
Route(s) of administration
Intramuscular use
Contact for public enquiries

Seqirus S.r.l.

Tel. +39 0577096405; +39 0577096401
E-mail: pip.seq@seqirus.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001830-PIP01-15-M02
Compliance opinion date
Compliance outcome
Positive

Decision

P/0188/2020: EMA decision of 15 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (Foclivia and associated names), (EMEA- 001830-PIP01-1

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