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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100514-PIP01-22	Gliadin Protease	Treatment of coeliac disease		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100503-PIP01-22	efavaleukin alfa	Treatment of ulcerative colitis	Not available at present	Other: Inflammatory Bowel Disease	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
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-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-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-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-100648-PIP01-22-M01 (update)	TECOVIRIMAT MONOHYDRATE	Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)	Tecovirimat SIGA Tecovirimat SIGA TPOXX	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100636-PIP01-22-M01 (update)	Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain	Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV)			PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100418-PIP01-22-M01 (update)	axicabtagene ciloleucel	Treatment of mature B-cell neoplasms	Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100519-PIP01-22	RSV preF protein	Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)			P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100421-PIP01-22	efavaleukin alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100572-PIP01-22	autologous bone marrow-derived mononuclear cell enriched white blood cells	Treatment of chronic limb-threatening ischemia		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/02/2023
MHRA-100574-PIP01-22	lixmabegagene relduparvovec	Treatment of GM1 gangliosidosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100556-PIP01-22	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100458-PIP01-22	Modakafusp alfa	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100135-PIP02-22	anti-CD40L humanised monoclonal antibody (SAR441344)	Treatment of progressive Multiple Sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100053-PIP01-21 -M02 (update)	IMDEVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022

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