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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-101149-PIP01-23-M01 (update)	elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)	Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)	Vimizim 1mg/ml concentrate for solution for infusion	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100093-PIP01-21-M03 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)	Rinvoq	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100406-PIP01-21-M02 (update)	Marstacimab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100249-PIP01-21-M02 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma	Trixeo Aerosphere Trixeo Aerosphere Trixeo Aerosphere BREZTRI AEROSPHERE	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100921-PIP01-23-M01 (update)	AVATROMBOPAG	Treatment of Idiopathic Thrombocytopenia Purpura Treatment of Thrombocytopenic Purpura Secondary to Liver Disease	Doptelet Avatrombopag	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100934-PIP01-23-M01 (update)	CARFILZOMIB	Treatment of acute lymphoblastic leukaemia	Kyprolis Kyprolis Kyprolis Kyprolis	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100901-PIP01-23-M02 (update)	CABOTEGRAVIR	Treatment of human immunodeficiency virus (HIV-1) infection	Vocabria Vocabria / Cabenuva Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria / Cabenuva Vocabria / Cabenuva Vocabria	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100951-PIP01-23-M02 (update)	FOSTEMSAVIR TROMETHAMINE	Treatment of human immunodeficiency virus (HIV-1) infection	RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA Rukobia 600 mg prolonged-release tablets	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100951-PIP01-23-M01 (update)	FOSTEMSAVIR TROMETHAMINE	Treatment of human immunodeficiency virus (HIV-1) infection	RUKOBIA RUKOBIA RUKOBIA RUKOBIA Rukobia 600 mg prolonged-release tablets	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100625-PIP01-22-M01 (update)	RISANKIZUMAB	Treatment of psoriasis	Skyrizi Skyrizi Skyrizi Skyrizi	Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100303-PIP01-21-M02 (update)	DARUNAVIR COBICISTAT EMTRICITABINE TENOFOVIR ALAFENAMIDE	Treatment of human immunodeficiency virus type-1 (HIV-1) infection	Symtuza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
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

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