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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100299-PIP01-21	Humanized monoclonal IgG1-based antibody	Treatment of spinal muscular atrophy	Not available at present	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100796-PIP01-22	Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation	Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100573-PIP01-22	Vorasidenib	Treatment of glioma		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100673-PIP01-22	Fidrisertib	Treatment of fibrodysplasia ossificans progressiva		Other: Musculoskeletal	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100731-PIP01-22	deucravacitinib	Treatment of systemic lupus erythematosus	SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	19/12/2023
MHRA-100679-PIP01-22	Talazoparib	Treatment of Ewing Sarcoma	Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/10/2023
MHRA-100102-PIP01-21-M02 (update)	INDACATEROL ACETATE MOMETASONE FUROATE	Treatment of asthma	Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler and its duplicate authorization Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/08/2023
MHRA-100095-PIP01-21-M03 (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	24/08/2023
MHRA-100094-PIP01-21-M02 (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	24/08/2023
MHRA-100786-PIP01-22-M01 (update)	TOFACITINIB CITRATE	Treatment of ulcerative colitis	XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100212-PIP01-21-M02 (update)	FINERENONE	Treatment of Chronic Kidney Disease	Kerendia Kerendia	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
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-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

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