MHRA-101362-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ZANAMIVIR
Invented Name
  • Relenza (inhalation powder)
  • Dectova (solution for infusion)
  • Dectova
  • Dectova
  • Relenza
  • Relenza
  • Relenza
  • Relenza
PIP Number MHRA-101362-PIP01-24-M01 (update)
Pharmaceutical form(s)
  • Solution for infusion
  • Inhalation powder, pre-dispensed
  • Solution for infusion
  • Inhalation powder, pre-dispensed
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Prevention of influenza
  • Treatment of influenza
Route(s) of administration
  • Intravenous use
  • INHALATION USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ZANAMIVIR.pdf
Published Date 15/08/2024