MHRA paediatric investigation plan

VAFSEO (vadadustat)

MHRA paediatric investigation plan MHRA-100412-PIP01-22-M02 (update) · Modification

Key facts

PIP number MHRA-100412-PIP01-22-M02 (update)
Product names VAFSEO
Active substances vadadustat
Therapeutic areas Haematology-Hemostaseology
Conditions Treatment of anaemia due to chronic disorders
Decision PM: decision on the application for modification of an agreed paediatric investigation plan.
Published Dec 7, 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:

Browse all MHRA paediatric investigation plans