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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-100443-PIP01-22-M01 (update)	BARICITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100116-PIP01-21-M02 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of cystic fibrosis	Kaftrio Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Kaftrio Kaftrio Trikafta Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100485-PIP01-22-M01 (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		25/05/2023
MHRA-100463-PIP01-22-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		25/05/2023
MHRA-100274-PIP01-21-M01 (update)	ELIGLUSTAT	Treatment of Gaucher Disease type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100214-PIP01-21-M03 (update)	RAVULIZUMAB	atypical haemolytic uremic syndrome (aHUS)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100213-PIP01-21-M03 (update)	RAVULIZUMAB	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)	Ultomiris	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100274-PIP01-21-M02 (update)	ELIGLUSTAT	Treatment of Gaucher Disease Type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100811-PIP01-22	Vamorolone	Treatment of Duchenne muscular dystrophy	AGAMREE	Other: Neuromuscular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100743-PIP01-22-M01 (update)	efgartigimod alfa	Treatment of generalised myasthenia gravis	Vyvgart Vyvgart Vyvgart	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	02/02/2023
MHRA-100451-PIP01-22-M02 (update)	fidanacogene elaparvovec	Treatment of congenital factor IX deficiency (haemophilia B)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100451-PIP01-22-M01 (update)	fidanacogene elaparvovec	Treatment of congenital factor IX deficiency (haemophilia B)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100025-PIP01-21-M02 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100499-PIP01-22-M01 (update)	Giroctocogene Fitelparvovec	Treatment of haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100405-PIP01-21-M01 (update)	LIRAGLUTIDE	Treatment of obesity	Saxenda Saxenda Saxenda	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100468-PIP01-22-M01 (update)	EPTINEZUMAB	Prevention of migraine headaches	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		02/02/2023
MHRA-100467-PIP01-22-M01 (update)	SEMAGLUTIDE	Treatment of obesity	Ozempic Ozempic 0.25 mg, 0.5 mg, 1 mg	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100462-PIP01-22-M01 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet syndrome	Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100440-PIP01-22-M01 (update)	BICTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE	Treatment of Human immunodeficiency virus (HIV-1) infection	Biktarvy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100225-PIP01-21-M01 (update)	recombinant parathyroid hormone	Treatment of hypoparathyroidism	Natpar Natpar	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023

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