MHRA paediatric investigation plan

Keytruda (PEMBROLIZUMAB)

MHRA paediatric investigation plan MHRA-100874-PIP01-23 · Waiver

Key facts

PIP number MHRA-100874-PIP01-23
Product names Keytruda
Active substances PEMBROLIZUMAB
Therapeutic areas Oncology
Conditions Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue), Treatment of Hodgkin lymphoma
Decision W: decision granting a waiver in all age groups for the listed condition(s).
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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