EMEA-002027-PIP02-17-M01 - paediatric investigation plan

Influenza virus surface antigens (haemagglutinin) of strain A (H1N1)

influenza virus surface antigens (haemagglutinin) of strain A (H3N2)

influenza virus surface antigens (haemagglutinin) of strain B  (Victoria lineage)

influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage)

Key facts

• Active Substance:
  • Influenza virus surface antigens (haemagglutinin) of strain A (H1N1)
  • influenza virus surface antigens (haemagglutinin) of strain A (H3N2)
  • influenza virus surface antigens (haemagglutinin) of strain B (Victoria lineage)
  • influenza virus surface antigens (haemagglutinin) of strain B (Yamagata lineage)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0340/2019
• PIP number:
  EMEA-002027-PIP02-17-M01
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of influenza infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/09/2019

Decision

P/0340/2019: EMA decision of 10 September 2019 on the acceptance of a modification of an agreed PIP for influenza virus surface antigens (haemagglutinin) of strain A (H1N1) / influenza virus surface antigens (haemagglutinin) of strain A (H3N2)...

AdoptedReference Number: EMA/480322/2019