MHRA paediatric investigation plan
ILUVIEN 190 micrograms intravitreal implant in applicator (FLUOCINOLONE ACETONIDE)
MHRA paediatric investigation plan MHRA-100156-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100156-PIP01-21-M01 (update) |
|---|---|
| Product names | 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 and 8 more |
| Active substances | FLUOCINOLONE ACETONIDE |
| Therapeutic areas | Ophthamology |
| Conditions | Treatment of non-infectious uveitis, Secondary prevention of non-infectious uveitis |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Mar 18, 2022 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: