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PIPS Search Results
PIP Number	Active Substance Sort ascending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100297-PIP01-21-M01 (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		24/08/2023
MHRA-100824-PIP01-22	perflubutane	Diagnostic evaluation of focal hepatic lesions	Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid	Diagnostic Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100738-PIP01-22	PEMIGATINIB	Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement	Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/08/2023
MHRA-100670-PIP01-22	Ibrexafungerp citrate	Treatment of invasive candidiasis	Brexafemme	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100430-PIP01-22	±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)	Treatment of post-traumatic stress disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100612-PIP01-22	Fosmanogepix	Treatment of invasive fungal infections		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100788-PIP01-22	favezelimab PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Not availble at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100721-PIP01-22	Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)	Treatment of mucopolysaccharidosis II (Hunter syndrome)		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100424-PIP01-22	zilebesiran sodium	Treatment of hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100966-PIP01-23	COVID-19 Vaccine (recombinant, adjuvanted)	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100578-PIP01-22	Cagrilintide SEMAGLUTIDE	Treatment of obesity	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100775-PIP01-22-M02 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	Livmarli (maralixibat chloride) LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	01/08/2023
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-100775-PIP01-22-M01 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	maralixibat chloride	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	01/08/2023
MHRA-100740-PIP01-22	Xevinapant	Treatment of head and neck epithelial malignant neoplasms	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100846-PIP01-23-M01 (update)	ENALAPRIL MALEATE	Treatment of heart failure		Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/06/2023
MHRA-100029-PIP01-21-M01 (update)	RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE COVID-19 vaccine (Ad26.COV2-S [recombinant])	Prevention of coronavirus disease-2019 (COVID-19)	COVID-19 vaccine Janssen Jcovden (previously COVID-19 Vaccine Janssen)	Infectious diseases Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100699-PIP01-22-M01 (update)	DIROXIMEL FUMARATE	Treatment of Multiple Sclerosis	Vumerity Vumerity Vumerity	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100733-PIP01-22	Botulinum toxin type E	Treatment of skin wrinkling		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100959-PIP01-23-M01 (update)	DOSTARLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).	Jemperli Jemperli Jemperli	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023

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