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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-100585-PIP01-22	Adintrevimab	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Bredaygio	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100209-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of obesity		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100287-PIP01-21	SEMAGLUTIDE	Treatment of obesity	Not available at present Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus Rybelsus	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100634-PIP01-22	Ceralasertib	Treatment of lung carcinoma (small cell and non-small cell carcinoma)		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		02/02/2023
MHRA-100472-PIP01-22	Tarlatamab	Treatment of small cell lung cancer (SCLC) Treatment of prostate malignant neoplasms.		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		02/02/2023
MHRA-100251-PIP01-21	DUPILUMAB	Chronic pruritus of unknown origin	Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		02/02/2023
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
MHRA-100169-PIP01-21-M01 (update)	BETIBEGLOGENE AUTOTEMCEL	Treatment of beta-thalassaemia	zynteglo	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100695-PIP01-22-M02 (update)	Etranacogene dezaparvovec	Treatment of haemophilia B	Hemgenix	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100442-PIP01-22-M01 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023

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