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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100027-PIP01-21	benzylamine derivative of benzofuran	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100091-PIP01-21	Rozanolixizumab	Treatment of Immune thrombocytopenia	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100062-PIP01-21	(14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate TEZACAFTOR DEUTIVACAFTOR	Treatment of Cystic Fibrosis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100100-PIP01-21	Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein	Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100109-PIP01-21	Islatravir	Prevention of human immunodeficiency virus (HIV-1) infection		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100165-PIP01-21	PF-06865571	Treatment of non-alcoholic steatohepatitis	PF-06865571	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100199-PIP01-21	efgartigimod alfa	Treatment of Pemphigus		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100265-PIP01-21	BARICITINIB	Treatment of alopecia areata	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100293-PIP01-21	lenzilumab	Treatment of coronavirus disease 2019 (COVID-19)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	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
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-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-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-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-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-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-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-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-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-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

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