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PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published
MHRA-100840-PIP01-23	Odronextamab	Treatment of mature B cell malignancies		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100678-PIP01-22	Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)	Treatment of uveitic macular oedema	Not available at present	Ophthamology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100446-PIP01-22	Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one	Treatment of Chronic Kidney Disease		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100754-PIP01-22	Live-attenuated La Reunion strain of chikungunya virus	Prevention of chikungunya virus disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100809-PIP01-22	Efruxifermin	Treatment of non-alcoholic steatohepatitis (NASH)	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100882-PIP01-23	Glucagon analogue linked to a human immunoglobulin Fc fragment	Treatment of congenital hyperinsulinism		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100878-PIP01-23	vibegron	Treatment of myoneurogenic bladder disorders		Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-101016-PIP01-23	ublituximab	Treatment of multiple sclerosis	Briumvi Briumvi	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	20/12/2023
MHRA-100593-PIP01-22	aticaprant	Treatment of Major Depressive Disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/01/2024
MHRA-100866-PIP01-23	obecabtagene autoleucel	Treatment of acute lymphoblastic leukaemia (ALL)		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/01/2024
MHRA-100872-PIP01-23	pudexacianinium chloride	Visualisation of ureter		Uro-Nephrology Gastroenterology-Hepatology Diagnostic Endocrinology-Gynaecology-Fertility-metabolism Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/01/2024
MHRA-101232-PIP01-23	palopegteriparatide	Treatment of hypoparathyroidism	Yorvipath Yorvipath	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100594-PIP01-22	N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide	Treatment of focal onset seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100920-PIP01-23	Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100680-PIP01-22	Influenza recombinant H7 haemagglutinin	Prevention of influenza infection		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100971-PIP01-23	Sipavibart (AZD3152)	Prevention of coronavirus disease 2019 (COVID-19)		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100558-PIP01-22	milvexian	Prevention of thromboembolism in patients with cardiovascular disease	Not available at present	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100698-PIP01-22	Nemvaleukin Alfa	Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue) Treatment of malignant neoplasms of the lymphoid tissue		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100789-PIP01-22	Fazirsiran	Treatment of congenital alpha-1 antitrypsin deficiency	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100797-PIP01-22	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)	Prevention of influenza disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024

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