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PIPS Search Results
PIP Number	Active Substance Sort ascending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published
MHRA-101304-PIP01-23-M01 (update)	FILGOTINIB MALEATE	Treatment of ulcerative colitis	Jyseleca Jyseleca Jyseleca Jyseleca Jyseleca	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	01/05/2024
MHRA-101249-PIP01-23-M01 (update)	Tovorafenib	Treatment of paediatric low grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	01/05/2024
MHRA-100372-PIP01-21-M01 (update)	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Alhemo Alhemo	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101262-PIP01-23-M01 (update)	DIENOGEST ETHINYLESTRADIOL	Prevention of pregnancy	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101123-PIP01-23-M01 (update)	BREXUCABTAGENE AUTOLEUCEL	Treatment of acute lymphoblastic leukaemia	Brexucabtagene autoleucel Brexucabtagene autoleucel Brexucabtagene autoleucel	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100916-PIP01-23-M01 (update)	ELUXADOLINE	Treatment of diarrhoea irritable bowel syndrome.	Viberzi Viberzi Viberzi Viberzi Truberzi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101027-PIP01-23-M01 (update)	ANIFROLUMAB	Treatment of Systemic Lupus Erythematosus	Saphnelo Saphnelo	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101141-PIP01-23-M01 (update)	mavacamten	Treatment of hypertrophic cardiomyopathy	CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101078-PIP01-23-M01 (update)	OLAPARIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).	Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100485-PIP01-22-M02 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100297-PIP01-21-M03 (update)	Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101044-PIP01-23-M01 (update)	INCLISIRAN SODIUM	Treatment of elevated cholesterol	Leqvio Leqvio Leqvio Leqvio	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101008-PIP01-23-M01 (update)	AMBRISENTAN	Pulmonary Arterial Hypertension	Volibris Volibris	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100562-PIP01-22	strontium-82 chloride/ rubidium-82 chloride	Visualisation of myocardial perfusion for diagnostic purposes	Ruby-Fill Ruby-Fill Ruby-Fill	Cardiovascular Diseases Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100840-PIP01-23-M01 (update)	Odronextamab	Treatment of mature B cell malignancies		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-101000-PIP01-23-M01 (update)	Rilzabrutinib	Treatment of Immune thrombocytopenia		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-100336-PIP01-21-M02 (update)	Soticlestat	Treatment of Dravet Syndrome Treatment of Lennox-Gastaut Syndrome		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-100225-PIP01-21-M02 (update)	PARATHYROID HORMONE	Treatment of hypoparathyroidism	Natpar	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-101024-PIP01-23-M01 (update)	gadoquatrane	Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging		Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100932-PIP01-23-M01 (update)	Peanut Flour	Treatment of peanut allergy	Palforzia PALFORZIA Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023

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