MHRA paediatric investigation plan

efinopegdutide (efinopegdutide)

MHRA paediatric investigation plan MHRA-101595-PIP01-24 · Agreement

Key facts

PIP number MHRA-101595-PIP01-24
Active substances efinopegdutide
Therapeutic areas Gastroenterology-Hepatology
Conditions Treatment of metabolic dysfunction-associated steatohepatitis
Decision P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Published Apr 8, 2025
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:

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