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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100409-PIP01-21-M01 (update)	autologous dendritic cells pulsed with autologous tumour cell lysate	Treatment of high grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100327-PIP01-21-M02 (update)	SELPERCATINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Retsevmo Retsevmo Retevmo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100222-PIP01-21-M02 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-101006-PIP01-23-M01 (update)	IMLIFIDASE	Prevention of graft rejection following solid organ transplantation	Idefirix Idefirix Idefirix Idefirix Idefirix	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100079-PIP01-21-M02 (update)	GILTERITINIB FUMARATE	Treatment of acute myeloid leukemia	Xospata Xospata	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100901-PIP01-23-M01 (update)	CABOTEGRAVIR	Treatment of human immunodeficiency virus (HIV-1) infection	Vocabria	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100993-PIP01-23-M01 (update)	QUIZARTINIB DIHYDROCHLORIDE	Treatment of acute myeloid leukaemia (AML)	VANFLYTA VANFLYTA VANFLYTA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100288-PIP01-21-M02 (update)	DENOSUMAB	Treatment of osteoporosis	Prolia Prolia	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100469-PIP01-22-M01 (update)	delgocitinib	Treatment of chronic hand eczema		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100909-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of Ewing's sarcoma.	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100910-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of glioma Treatment of neuroblastoma	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100270-PIP01-21-M01 (update)	crinecerfont	Treatment of congenital adrenal hyperplasia		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100524-PIP01-22-M02 (update)	gadopiclenol	Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes	Elucirem Elucirem	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100523-PIP01-22-M02 (update)	gadopiclenol	Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.	Elucirem Elucirem	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100352-PIP01-21-M02 (update)	AVAPRITINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100579-PIP01-22-M03 (update)	Maribavir	Treatment of cytomegalovirus (CMV) infection	Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtenicty Livtencity Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100066-PIP01-21-M01 (update)	efgartigimod alfa	Treatment of myasthenia gravis	Vyvgart Vyvgart Vyvgart	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100443-PIP01-22-M02 (update)	BARICITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100818-PIP01-22-M01 (update)	BEMPEDOIC ACID	Treatment of elevated cholesterol	Nilemdo® (bempedoic acid) tablets Nilemdo® (bempedoic acid) film-coated tablets Nilemdo® (bempedoic acid) film-coated tablets Nexletol® (bempedoic acid) tablets Nilemdo® Nilemdo® Nilemdo® Nexletol® Nilemdo®	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100907-PIP01-23-M01 (update)	CEFTOLOZANE TAZOBACTAM	Treatment of pneumonia	ZERBAXA ZERBAXA ZERBAXA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023

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