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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
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-100604-PIP01-22-M01 (update)	REMDESIVIR	Treatment of coronavirus disease 2019 (COVID-19)	VEKLURY VEKLURY VEKLURY	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	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-100406-PIP01-21-M01 (update)	Marstacimab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100471-PIP01-22-M01 (update)	SETMELANOTIDE	Treatment of appetite and general nutrition disorders	IMCIVREE IMCIVREE IMCIVREE IMCIVREE	Nutrition	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100118-PIP01-21-M02 (update)	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100093-PIP01-21-M02 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100579-PIP01-22-M02 (update)	Maribavir	Treatment of cytomegalovius (CMV) infection	Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100579-PIP01-22-M01 (update)	Maribavir	Treatment of cytomegalovius (CMV) infection	Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100695-PIP01-22-M01 (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-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-100087-PIP01-21-M02 (update)	LACOSAMIDE	Treatment of generalised epilepsy and epileptic syndromes.		Neurology	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-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-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-100482-PIP01-22	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick Disease type C (NPC)		Neurology	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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