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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 descending
MHRA-100598-PIP01-22	Cobolimab	Treatment of lung cancer	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
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-100845-PIP01-23-M01 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	VOCABRIA and CABENUVA Apretude APRETUDE Apretude VOCABRIA/APRETUDE	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		20/06/2023
MHRA-100845-PIP01-23-M02 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	N/A VOCABRIA AND APRETUDE Apretude N/A N/A N/A Apretude Apretude	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	20/06/2023
MHRA-100706-PIP01-22	METHYLPHENIDATE HYDROCHLORIDE	Treatment of attention-deficit hyperactivity disorder	Not available at present Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		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-100681-PIP01-22	Lomitapide	Treatment of (heterozygous or homozygous) familial hypercholesterolaemia	Lojuxta hard capsule	Other: Hypercholesterolaemia (HoFH)	PM: decision on the application for modification of an agreed paediatric investigation plan.	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-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-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-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-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-100195-PIP01-21-M02 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100580-PIP01-22-M01 (update)	CEMIPLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Cemiplimab	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100392-PIP01-21-M03 (update)	TOZINAMERAN TOZINAMERAN/ FAMTOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified) 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		30/06/2023
MHRA-100515-PIP01-22-M01 (update)	VORTIOXETINE	Treatment of Major Depressive Disorder	Brintellix Brintellix Brintellix	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/06/2023
MHRA-100544-PIP01-22-M01 (update)	sebetralstat	Treatment of hereditary angioedema		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100716-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of chronic Graft versus Host Disease	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	30/06/2023
MHRA-100727-PIP01-22-M01 (update)	ALPELISIB	Treatment of PIK3CA related overgrowth spectrum	Vijoice Piqray Vijoice	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100802-PIP01-22-M01 (update)	roxadustat	Treatment of anaemia due to chronic disorders	EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023

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