MHRA-100156-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • FLUOCINOLONE ACETONIDE
Invented Name
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 micrograms intravitreal implant in applicator
  • ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru
  • ILUVIEN
  • Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator
  • ILUVIEN 190 microgrammi impianto intravitreale in applicatore
  • ILUVIEN 190 microgrammes, implant intravitréen avec applicateur
  • ILUVIEN 190 microgram, intravitreaal implant in applicator
  • Iluvien 190 mikrogram intravitrealt implantat i applikator
  • ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze
  • ILUVIEN 190 microgramas implante intravítreo em aplicador
  • ILUVIEN 190 microgramos implante intravítreo en aplicador
  • Iluvien 190 mikrogram intravitrealt implantat i applikator
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
  • ILUVIEN fluocinolone acetonide 190 micrograms intravitreal implant in applicator
PIP Number MHRA-100156-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Intravitreal implant in applicator
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
  • Treatment of non-infectious uveitis
  • Secondary prevention of non-infectious uveitis
Route(s) of administration
Route(s) of administration:
  • Intravitreal 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):FLUOCINOLONE ACETONIDE.pdf
Published Date 18/03/2022