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Displaying 921 - 940 of 970

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100043-PIP01-21	zilucoplan	Treatment of myasthenia gravis	Zilbrysq Zilqivik	Neurology Other: Neurodegenerative disorder, auto-immune disease/dysfunction	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/03/2022
MHRA-100079-PIP01-21-M01 (update)	gilteritinib (as fumarate)	Treatment of acute myeloid leukaemia	Xospata Xospata	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/03/2022
MHRA-100044-PIP01-21	seltorexant	Treatment of major depressive disorder (MDD)	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/03/2022
MHRA-100080-PIP01-21	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of Immune Thrombocytopenic Purpura		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021
MHRA-100203-PIP01-21-M01 (update)	Avacopan	Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis	Tavneos	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021
MHRA-100160-PIP01-21-M01 (update)	TOCILIZUMAB	Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy	RoActemra RoActemra	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100154-PIP01-21-M01 (update)	Cotadutide	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100142-PIP01-21	Synthetic Hypericin	Treatment of cutaneous T-cell lymphoma	HyBryte	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021
MHRA-100148-PIP01-21-M01 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms	Lenvima Kisplyx Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100128-PIP01-21-M01 (update)	bis-choline tetrathiomolybdate	Treatment of Wilson disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100131-PIP01-21	ATEZOLIZUMAB	Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)	Tecentriq Tecentriq Tecentriq Tecentriq	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021
MHRA-100111-PIP01-21	DORAVIRINE Islatravir	Treatment of human immunodeficiency virus-1 (HIV-1) infection.		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		17/12/2021
MHRA-100098-PIP01-21-M01 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna Translarna Translarna Translarna Translarna Translarna Translarna Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100097-PIP01-21-M01 (update)	eladocagene exuparvovec	Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency	Upstaza	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100095-PIP01-21-M01 (update)	DORAVIRINE	Treatment of human immunodeficiency virus-1 (HIV-1) infection	Pifeltro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100094-PIP01-21-M01 (update)	DORAVIRINE LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus-1 (HIV-1) infection	Delstrigo	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100081-PIP01-21	Zibotentan DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE	Treatment of Chronic Kidney Disease	Not available at present	Other: Renal Disease	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021
MHRA-100074-PIP01-21	GABAPENTIN	Treatment of Postherpetic Neuralgia	Gralise	Neurology Pain	W: decision granting a waiver in all age groups for the listed condition(s).	No		17/12/2021
MHRA-100040-PIP01-21-M01 (update)	Cotadutide	Treatment of Type 2 Diabetes Mellitus		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100039-PIP01-21-M01 (update)	Cotadutide	Treatment of non-alcoholic steatohepatitis (NASH)		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021

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