MHRA-101162-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • LETERMOVIR
Invented Name
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PRVEYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • tablet
  • PREVYMIS
PIP Number MHRA-101162-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablets
  • Granules
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of cytomegalovirus infection
Route(s) of administration
  • Oral use
  • INTRAVENOUS USE
PIP applicant
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 opinion date
15/04/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101162-PIP01-23-M01 -C

Decision Document

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