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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100547-PIP01-22-M02 (update)	PEGINTERFERON BETA-1A	Treatment of multiple sclerosis.	Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy	Neurology	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-100440-PIP01-22-M02 (update)	EMTRICITABINE TENOFOVIR ALAFENAMIDE BICTEGRAVIR	Treatment of Human immunodeficiency virus (HIV) infection	Biktarvy Biktarvy	Infectious diseases	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-100117-PIP01-21-M03 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/01/2024
MHRA-100991-PIP01-23	Maralixibat chloride	Treatment of progressive familial intrahepatic cholestasis (PFIC)	LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100162-PIP01-21-M02 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100932-PIP01-23-M02 (update)	Defatted powder of peanuts	Treatment of peanut allergy	Palforzia Palforzia Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	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
MHRA-100188-PIP01-21-M02 (update)	lebrikizumab	treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101028-PIP01-23-M01 (update)	Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)	Prevention of cholera	Vaxchora	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100642-PIP01-22-M02 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO Tremelimumab AstraZeneca	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-101004-PIP01-23-M01 (update)	APIXABAN	Treatment of venous thromboembolism	Eliquis Eliquis Eliquis Eliquis	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100949-PIP01-23-M01 (update)	Delandistrogene moxeparvovec	Treatment of Duchenne muscular dystrophy	Not available	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100482-PIP01-22-M01 (update)	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick disease type C	Not available at present	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100141-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA FASENRA PEN	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101117-PIP01-23-M01 (update)	ORITAVANCIN	Treatment of acute bacterial skin and skin structure infections (ABSSSI)	Tenkasi Tenkasi Orbactiv Tenkasi Tenkasi	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-101188-PIP01-23-M01 (update)	fosdenopterin	Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A	Nulibry	Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023

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