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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-100099-PIP01-21-M04 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact (in Italy: Nubriveo)	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100195-PIP01-21-M04 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluxa Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-101212-PIP01-23-M01 (update)	CEFEPIME DIHYDROCHLORIDE MONOHYDRATE enmetazobactam	Treatment of infections caused by gram-negative organisms	EXBLIFEP	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/04/2024
MHRA-100586-PIP01-22-M02 (update)	DUPILUMAB	Treatment of asthma	Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100543-PIP01-22-M02 (update)	DOLUTEGRAVIR LAMIVUDINE	Treatment of Human Immunodeficiency virus (HIV - 1) Infection	Dovato Dovato Dovato	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100037-PIP01-21-M02 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/dysfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100989-PIP01-23-M01 (update)	DERMATOPHAGOIDES FARINAE DERMATOPHAGOIDES PTERONYSSINUS	Treatment of asthma Treatment of allergic rhinitis	ACARIZAX and associated names ACARIZAX ACARIZAX ACARIZAX ACARIZAX AMITEND ACARIZAX AITARO ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACCARIZAX	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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-100046-PIP01-21-M04 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri Ontozry	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100564-PIP01-22-M02 (update)	TEDIZOLID PHOSPHATE	Treatment of acute bacterial skin and skin structure infections	Sivextro Sivextro Sivextro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100479-PIP01-22-M02 (update)	POSACONAZOLE	Prevention of invasive fungal infections Treatment of invasive fungal infections	Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil Noxafil	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100468-PIP01-22-M02 (update)	EPTINEZUMAB	Prevention of migraine headaches	Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100462-PIP01-22-M02 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet Syndrome	Fintepla Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100442-PIP01-22-M02 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-100351-PIP01-21-M02 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	Juluca 50mg/25mg film-coated tablets JULUCA JULUCA JULUCA JULUCA JULUCA JASUPA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100068-PIP01-21-M02 (update)	VEDOLIZUMAB	Treatment of Pouchitis	Entyvio Entyvio		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-100300-PIP01-21-M03 (update)	DARUNAVIR COBICISTAT	Treatment of human immunodeficiency virus (HIV-1) infection		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024

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