MHRA paediatric investigation plan

sabatolimab (sabatolimab)

MHRA paediatric investigation plan MHRA-100858-PIP01-23 · Waiver

Key facts

PIP number MHRA-100858-PIP01-23
Active substances sabatolimab
Therapeutic areas Oncology
Conditions Treatment of myelodysplastic syndromes
Decision W: decision granting a waiver in all age groups for the listed condition(s).
Published Jan 30, 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:

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