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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
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
MHRA-100149-PIP01-21-M02 (update)	NVX-CoV2373	Prevention of coronavirus disease 2019 (COVID-19)	Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted) Nuvaxovid Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100050-PIP01-21-M01 (update)	efgartigimod alfa	Treatment of immune thrombocytopenia.	Vyvgart Vyvgart	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-101079-PIP01-23-M01 (update)	ZANUBRUTINIB	Treatment of lymphoplasmacytic lymphoma Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)	Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100931-PIP01-23-M01 (update)	mirikizumab	Treatment of ulcerative colitis Treatment of Crohn's disease		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100758-PIP01-22-M01 (update)	BEZLOTOXUMAB	Prevention of recurrence of Clostridioides difficile infection	ZINPLAVA ZINPLAVA ZINPLAVA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100343-PIP01-21-M02 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension Treatment of systemic sclerosis Treatment of idiopathic pulmonary fibrosis	Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023

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