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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100552-PIP01-22-M01 (update)	RILPIVIRINE HYDROCHLORIDE	Treatment of human immunodeficiency virus (HIV-1) infection	edurant edurant	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100496-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of acute Graft versus Host Disease (aGvHD)	Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100517-PIP01-22-M01 (update)	APREMILAST	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)	Otezla Otezla Otezla	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100392-PIP01-21-M02 (update)	TOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100518-PIP01-22-M01 (update)	APREMILAST	Treatment of Behçet’s Disease	Otezla Otezla Otezla Otezla	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
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-100443-PIP01-22-M01 (update)	BARICITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100214-PIP01-21-M03 (update)	RAVULIZUMAB	atypical haemolytic uremic syndrome (aHUS)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100213-PIP01-21-M03 (update)	RAVULIZUMAB	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)	Ultomiris	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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

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