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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-101333-PIP01-24	2-(3,5-dichloro-1-methyl-indazol-4-yl)-1-[(1S,3R)-3-(hydroxymethyl)-5-(1-hydroxy-1-methyl-ethyl)-1-methyl-3,4-dihydro-1H-isoquinolin-2-yl]ethanone monohydrate	Treatment of Parkinson's disease		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	28/10/2024
MHRA-101292-PIP01-23	Complement Factor B Antisense Oligonucleotide (RO7434656)	Treatment of primary immunoglobulin A nephropathy	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	28/10/2024
MHRA-101307-PIP01-23	inaxaplin	Treatment of apolipoprotein L1 (APOL1) -mediated kidney disease		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	28/10/2024
MHRA-101047-PIP01-23	vesleteplirsen	Treatment of Duchenne muscular dystrophy		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	28/10/2024
MHRA-100242-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory tract disease caused by respiratory syncytial virus.		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/10/2024
MHRA-100139-PIP01-21	Teplizumab	Prevention or delay of (clinical) type 1 diabetes mellitus		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	09/10/2024
MHRA-101170-PIP01-23	IRINOTECAN HYDROCHLORIDE TRIHYDRATE	Treatment of pancreatic cancer	ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion ONIVYDE pegylated liposomal	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101132-PIP01-23	Vepdegestrant	Treatment breast malignant neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-101120-PIP01-23	RVT-802 (allogeneic cultured postnatal thymus tissue-derived product)	Treatment of congenital athymia	RETHYMIC RETHYMIC	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024
MHRA-100351-PIP01-21-M03 (update)	RILPIVIRINE DOLUTEGRAVIR	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-100197-PIP01-21-M03 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101439-PIP01-24-M01 (update)	(R)-1-(1-acryloylpiperidin-3-yl)-4-amino-3-(4-phenoxyphenyl)-1H-imidazo[4,5-c]pyridin-2(3H)-one	Treatment of Multiple Sclerosis		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101513-PIP01-24-M01 (update)	ERTUGLIFLOZIN L-PYROGLUTAMIC ACID	Treatment of Type 2 Diabetes Mellitus	Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro Steglatro	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101494-PIP01-24-M01 (update)	LUSPATERCEPT	Treatment of myelodysplastic syndromes. Treatment of beta-thalassaemia.	Reblozyl Reblozyl Reblozyl Reblozyl Reblozyl	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101078-PIP01-23-M02 (update)	OLAPARIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).	Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101112-PIP01-23-M01 (update)	Interleukin-23 receptor antagonist peptide (JNJ-77242113)	Treatment of psoriasis.		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101468-PIP01-24	DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE baxdrostat	Treatment of Chronic Kidney Disease		Uro-Nephrology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/10/2024
MHRA-100239-PIP01-21-M01 (update)	Multivalent pneumococcal polysaccharide conjugate to carrier protein	Prevention of disease caused by Streptococcus pneumoniae	Not available at present	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	03/10/2024
MHRA-101422-PIP01-24	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A/H1N1, A/H3N2, and B/Victoria and the N-terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (mRNA-1083)	Prevention of influenza and coronavirus disease 2019 (COVID-19)		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024
MHRA-101378-PIP01-24	UPADACITINIB	Treatment of hidradenitis suppurativa	Rinvoq	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2024

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