MHRA-100195-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • BALOXAVIR MARBOXIL
Invented Name
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
PIP Number MHRA-100195-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules for oral suspension.
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Treatment of Influenza
  • Prevention of Influenza
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email uk.dra@roche.com
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):BALOXAVIR MARBOXIL.pdf
Published Date 30/06/2023