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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100123-PIP01-21-M01 (update)	SARILUMAB	Treatment of chronic idiopathic arthritis	Kevzara Kevzara Kevzara Kevzara Kevzara	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100117-PIP01-21-M01 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100143-PIP01-21-M01 (update)	TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of chronic viral hepatitis B	Vemlidy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100130-PIP01-21-M01 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100058-PIP01-21-M01 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100046-PIP01-21-M02 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100037-PIP01-21-M01 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/disfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100448-PIP01-22	RUXOLITINIB PHOSPHATE	Treatment of vitiligo	OPZELURA	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100330-PIP01-21	Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)	Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)		Other: Metabolic disorders	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100315-PIP01-21	Brensocatib	Treatment of non‐cystic fibrosis bronchiectasis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100316-PIP01-21	latozinemab	Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100364-PIP01-21	Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01	Prevention of lower respiratory tract disease caused by respiratory syncytial virus	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100304-PIP01-21	rozibafusp alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation Other: Inflammation-Rheumatology SLE	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100305-PIP01-21	Single chain urokinase plasminogen activator (scuPA)	Treatment of pleural effusion		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100267-PIP01-21	Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene	Treatment of beta-thalassemia intermedia and major		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100266-PIP01-21	Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene	Treatment of sickle cell disease		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100270-PIP01-21	crinecerfont	Treatment of congenital adrenal hyperplasia		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100244-PIP01-21	surufatinib	Treatment of malignant neoplasms Malignant neoplasms of haematopoietic and lymphoid tissue	Sevsury Sulanda	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100224-PIP01-21	Etrasimod L-arginine	Treatment of ulcerative colitis	Not available at present	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100396-PIP01-21	sugemalimab	Treatment of non-small cell lung cancer (NSCLC)		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022

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