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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 descending
MHRA-100213-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of Paroxysmal Nocturnal Haemoglobinuria	Ultomiris Ultomiris Ultomiris Ultomiris	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100214-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of atypical Haemolytic Uremic Syndrome	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100216-PIP01-21-M01 (update)	TRALOKINUMAB	Treatment of atopic dermatitis	Adtralza Adtralaza Adtralza	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100217-PIP01-21-M01 (update)	ERIBULIN	Treatment of soft tissue sarcoma	Halaven Halaven	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	17/05/2022
MHRA-100229-PIP01-21-M01 (update)	NINTEDANIB	Treatment of fibrosing Interstitial Lung Diseases (ILD)	Ofev Vargatef Ofev Vargatef	Pneumology - Allergology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100247-PIP01-21-M01 (update)	BEROTRALSTAT DIHYDROCHLORIDE	Treatment of hereditary angioedema	Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100248-PIP01-21-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100262-PIP01-21-M01 (update)	DALBAVANCIN HYDROCHLORIDE	Treatment of acute bacterial skin and skin structure infections (ABSSSI)	Xydalba Xydalba Dalvance Xydalba	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100264-PIP01-21-M01 (update)	spesolimab	Treatment of Generalised Pustular Psoriasis Prevention of Generalised Pustular Psoriasis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100320-PIP01-21-M01 (update)	REMDESIVIR	Treatment of coronavirus disease 2019 (COVID-19)	VEKLURY VEKLURY VEKLURY	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100327-PIP01-21-M01 (update)	SELPERCATINIB	Treatment 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.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100342-PIP01-21-M01 (update)	arimoclomol citrate	Treatment of Niemann-Pick Disease, type C	MIPLYFFA	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100412-PIP01-22-M01 (update)	vadadustat	Treatment of anaemia due to chronic disorders	VAFSEO VAFSEO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100426-PIP01-22-M01 (update)	ligelizumab	Treatment of chronic spontaneous urticaria		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100195-PIP01-21-M01 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/05/2022
MHRA-100027-PIP01-21	benzylamine derivative of benzofuran	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100091-PIP01-21	Rozanolixizumab	Treatment of Immune thrombocytopenia	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100062-PIP01-21	(14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate TEZACAFTOR DEUTIVACAFTOR	Treatment of Cystic Fibrosis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100100-PIP01-21	Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein	Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100109-PIP01-21	Islatravir	Prevention of human immunodeficiency virus (HIV-1) infection		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022

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