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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
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-100332-PIP01-21-M01 (update)	sotatercept	Treatment of pulmonary arterial hypertension	Not available at present	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		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-100844-PIP01-23-M01 (update)	IVACAFTOR	Treatment of cystic fibrosis.	Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco	Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	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-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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
MHRA-100430-PIP01-22	±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)	Treatment of post-traumatic stress disorder	Not available at present	Psychiatry	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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