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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100505-PIP01-22-M01 (update)	copanlisib dihydrochloride	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) Treatment of mature B-cell neoplasms	Aliqopa Aliqopa Aliqopa Aliqopa Aliqopa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100116-PIP01-21-M02 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of cystic fibrosis	Kaftrio Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Kaftrio Kaftrio Trikafta Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100485-PIP01-22-M01 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100463-PIP01-22-M01 (update)	spesolimab	Treatment of Generalised Pustular Psoriasis Prevention of Generalised Pustular Psoriasis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100274-PIP01-21-M01 (update)	ELIGLUSTAT	Treatment of Gaucher Disease type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100274-PIP01-21-M02 (update)	ELIGLUSTAT	Treatment of Gaucher Disease Type 2 Treatment of Gaucher Disease Type 1 and Type 3	CERDELGA	Other: Lysosomal Storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100811-PIP01-22	Vamorolone	Treatment of Duchenne muscular dystrophy	AGAMREE	Other: Neuromuscular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100637-PIP01-22	Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus	Treatment of chronic hepatitis D infection	Not available at present	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100545-PIP01-22	Lutetium (177Lu) edotreotide	Treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100316-PIP02-22	latozinemab	Treatment of Amyotrophic lateral sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100224-PIP02-22	Etrasimod L-arginine	Treatment of Crohn’s 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-100186-PIP01-21	depemokimab	Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)	Depemokimab	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100635-PIP01-22	CEDAZURIDINE DECITABINE	Treatment of acute myeloid leukaemia	INQOVI INQOVI Inqovi 35/100 INAQOVI	Haematology-Hemostaseology Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100606-PIP01-22	sparsentan	Treatment of focal segmental glomerulosclerosis	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100559-PIP01-22	mitapivat	Treatment of thalassaemia	PYRUKYND PYRUKYND	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100628-PIP01-22	Sibeprenlimab	Treatment of primary immunoglobulin A nephropathy		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100439-PIP01-22	Asundexian	Prevention of arterial thromboembolism	Not available at present.	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100588-PIP01-22	UB-612	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present		P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100345-PIP01-21	Magrolimab	Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia) Treatment of acute myeloid leukaemia		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100508-PIP01-22	tezepelumab	Treatment of chronic spontaneous urticaria	Not available at present TEZSPIRE	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023

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