MHRA paediatric investigation plan

Venglustat (Venglustat)

MHRA paediatric investigation plan MHRA-101314-PIP01-23 · Agreement

Key facts

PIP number MHRA-101314-PIP01-23
Active substances Venglustat
Therapeutic areas Endocrinology-Gynaecology-Fertility-metabolism
Conditions Treatment of Gaucher Disease Type 2, Treatment of Gaucher Disease type 3
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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