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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-100776-PIP01-22-M01 (update)	Nemolizumab	Treatment of atopic dermatitis.	Not yet defined	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100676-PIP01-22-M01 (update)	EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of human immunodeficiency virus (HIV-1) infection.	Descovy Descovy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100801-PIP01-22	eplontersen	Treatment of transthyretin-mediated amyloidosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100806-PIP01-22	ALPELISIB	Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours) Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours) Treatment of Peritoneal cancer (excluding blastomas and sarcomas).	Piqray Piqray	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100301-PIP02-22	Nipocalimab	Treatment of Bullous Pemphigoid		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100677-PIP01-22-M01 (update)	COBICISTAT	Treatment of human immunodeficiency virus type-1 (HIV-1) infection	Tybost Tybost	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100778-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of ulcerative colitis	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100690-PIP01-22-M01 (update)	IMIPENEM MONOHYDRATE CILASTATIN SODIUM RELEBACTAM MONOHYDRATE	Treatment of infections caused by gram-negative organisms.	RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100330-PIP01-21 -M01 (update)	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)	Not available at present	Other: Metabolic disorders	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100268-PIP01-21-M03 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100268-PIP01-21-M02 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100750-PIP01-22-M01 (update)	setrusumab	Treatment of osteogenesis imperfecta		Other: Skeletal	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100276-PIP01-21-M02 (update)	BRODALUMAB	Treatment of psoriasis	Kyntheum Lumicef Siliq	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100807-PIP01-22-M01 (update)	RIMEGEPANT SULFATE	Treatment of migraine headaches	Vydura	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100687-PIP01-22-M01 (update)	OBINUTUZUMAB	Treatment of systemic lupus erythematosus	Gazyvaro Gazyvaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100297-PIP01-21-M01 (update)	Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)	Treatment of atopic dermatitis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100824-PIP01-22	perflubutane	Diagnostic evaluation of focal hepatic lesions	Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid	Diagnostic Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100738-PIP01-22	PEMIGATINIB	Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement	Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100820-PIP01-22	Tirzepatide	Treatment of obesity	Mounjaro	Other: Obesity, Overweight	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100670-PIP01-22	Ibrexafungerp citrate	Treatment of invasive candidiasis	Brexafemme	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023

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