MHRA-100195-PIP01-21-M04 (update)

Key Facts

Active Substance
Active Substance:
  • BALOXAVIR MARBOXIL
Invented Name
  • Xofluxa
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
PIP Number MHRA-100195-PIP01-21-M04 (update)
Pharmaceutical form(s)
  • Film-coated tablets
  • 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100195-PIP01-21-M04-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BALOXAVIR MARBOXIL.pdf
Published Date 30/04/2024