MHRA paediatric investigation plan

Olumiant (BARICITINIB)

MHRA paediatric investigation plan MHRA-100114-PIP01-21 · Agreement

Key facts

PIP number MHRA-100114-PIP01-21
Product names Olumiant
Active substances BARICITINIB
Therapeutic areas Immunology -Rheumatology-Transplantation
Conditions Treatment of coronavirus disease 2019 (COVID-19)
Decision P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Published Nov 3, 2021
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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