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Displaying 41 - 60 of 162

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100118-PIP02-22	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus Ocrevus	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100788-PIP01-22	favezelimab PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Not availble at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100513-PIP01-22	efgartigimod alfa	Treatment of dermatomyositis Treatment of immune-mediated necrotizing myopathy Treatment of polymyositis (including antisynthetase syndrome)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100721-PIP01-22	Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)	Treatment of mucopolysaccharidosis II (Hunter syndrome)		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100424-PIP01-22	zilebesiran sodium	Treatment of hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100966-PIP01-23	COVID-19 Vaccine (recombinant, adjuvanted)	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100578-PIP01-22	Cagrilintide SEMAGLUTIDE	Treatment of obesity	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100719-PIP01-22	LUTETIUM (177LU) OXODOTREOTIDE	Treatment of gastroenteropancreatic neuroendocrine tumours	Lutathera 370 MBq/mL solution for infusion Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera Lutathera	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100110-PIP02-22	Yellow fever virus, strain vYF-247	Prevention of yellow fever disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100737-PIP01-22	Clazakizumab	Prevention and treatment of rejection of transplanted kidney		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100371-PIP01-21	Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA	Treatment of Junctional Epidermolysis Bullosa (JEB)	HOLOGENE 5	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100792-PIP01-22	OBINUTUZUMAB	Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies	Gazyvaro	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100466-PIP01-22	zilovertamab vedotin	Treatment of malignant neoplasms of haematopoietic and lymphoid tissue Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)	not available at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/06/2023
MHRA-100126-PIP01-21-M01 (update)	Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene	Duchenne Muscular Dystrophy	fordadistrogene movaparvovec	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	15/06/2023
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-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-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

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