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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-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-100118-PIP02-22	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus Ocrevus	Neurology	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-100513-PIP01-22	efgartigimod alfa	Treatment of dermatomyositis Treatment of immune-mediated necrotizing myopathy Treatment of polymyositis (including antisynthetase syndrome)		Immunology -Rheumatology-Transplantation	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-100641-PIP01-22-M02 (update)	DURVALUMAB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)	IMFINZI IMFINZI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		14/08/2023
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-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-100148-PIP01-21-M03 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma	Lenvima Lenvima Kisplyx Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	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-100164-PIP01-21-M02 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100717-PIP01-22-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100130-PIP01-21-M02 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		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-100351-PIP01-21-M01 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	JULUCA JULUCA JULUCA JULUCA JASUPA Juluca 50mg/25mg film-coated tablets JULUCA 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		30/06/2023
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

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