MHRA paediatric investigation plan

Rinvoq (UPADACITINIB)

MHRA paediatric investigation plan MHRA-100093-PIP01-21-M03 (update) · Modification

Key facts

PIP number MHRA-100093-PIP01-21-M03 (update)
Product names Rinvoq
Active substances UPADACITINIB
Therapeutic areas Immunology -Rheumatology-Transplantation
Conditions Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
Decision PM: decision on the application for modification of an agreed paediatric investigation plan.
Published Dec 19, 2023
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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