MHRA paediatric investigation plan

Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene (Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene)

MHRA paediatric investigation plan MHRA-100374-PIP01-21 · Waiver

Key facts

PIP number MHRA-100374-PIP01-21
Active substances Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene
Therapeutic areas Neurology
Conditions Treatment of frontotemporal dementia
Decision W: decision granting a waiver in all age groups for the listed condition(s).
Published Sep 27, 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:

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