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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-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-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-100271-PIP01-21-M01 (update)	LINAGLIPTIN	Treatment of Type 2 Diabetes Mellitus	Trajenta Trajenta	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	02/02/2023
MHRA-100031-PIP01-21-M02 (update)	PALBOCICLIB	Treatment of Ewing sarcoma (EWS)	Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance blisters in an outer carton/21 and 63 tablets Ibrance	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100023-PIP01-21-M02 (update)	bimekizumab	Treatment of psoriasis	Bimzelx Bimzelx Bimzelx	Dermatology	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-100272-PIP01-21-M01 (update)	EMPAGLIFLOZIN	Treatment of Type 2 Diabetes Mellitus	Jardiance Jardiance	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	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

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