MHRA paediatric investigation plan
ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion (IRINOTECAN HYDROCHLORIDE TRIHYDRATE)
MHRA paediatric investigation plan MHRA-101170-PIP01-23 · Waiver
Key facts
| PIP number | MHRA-101170-PIP01-23 |
|---|---|
| Product names | ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion, ONIVYDE pegylated liposomal |
| Active substances | IRINOTECAN HYDROCHLORIDE TRIHYDRATE |
| Therapeutic areas | Oncology |
| Conditions | Treatment of pancreatic cancer |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Oct 3, 2024 |
| 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: