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PIP Number	Active Substance Sort ascending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published
MHRA-100173-PIP01-21	PACLITAXEL	Treatment of soft tissue sarcoma	Paxorlea	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/11/2021
MHRA-101304-PIP01-23-M01 (update)	FILGOTINIB MALEATE	Treatment of ulcerative colitis	Jyseleca Jyseleca Jyseleca Jyseleca Jyseleca	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	01/05/2024
MHRA-101249-PIP01-23-M01 (update)	Tovorafenib	Treatment of paediatric low grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	01/05/2024
MHRA-100372-PIP01-21-M01 (update)	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Alhemo Alhemo	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101262-PIP01-23-M01 (update)	DIENOGEST ETHINYLESTRADIOL	Prevention of pregnancy	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101123-PIP01-23-M01 (update)	BREXUCABTAGENE AUTOLEUCEL	Treatment of acute lymphoblastic leukaemia	Brexucabtagene autoleucel Brexucabtagene autoleucel Brexucabtagene autoleucel	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100916-PIP01-23-M01 (update)	ELUXADOLINE	Treatment of diarrhoea irritable bowel syndrome.	Viberzi Viberzi Viberzi Viberzi Truberzi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101027-PIP01-23-M01 (update)	ANIFROLUMAB	Treatment of Systemic Lupus Erythematosus	Saphnelo Saphnelo	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101141-PIP01-23-M01 (update)	mavacamten	Treatment of hypertrophic cardiomyopathy	CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS CAMZYOS	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101078-PIP01-23-M01 (update)	OLAPARIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).	Lynparza Lynparza Lynparza Lynparza Lynparza Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100485-PIP01-22-M02 (update)	AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide	Treatment of acute myeloid leukaemia	Tapotoclax	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100297-PIP01-21-M03 (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	30/04/2024
MHRA-101044-PIP01-23-M01 (update)	INCLISIRAN SODIUM	Treatment of elevated cholesterol	Leqvio Leqvio Leqvio Leqvio	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-101008-PIP01-23-M01 (update)	AMBRISENTAN	Pulmonary Arterial Hypertension	Volibris Volibris	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100301-PIP05-23	Nipocalimab	Treatment of Idiopathic inflammatory myopathies		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-101118-PIP01-23	5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7	Treatment of head and neck squamous cell carcinoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-101115-PIP01-23	Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)	Treatment of Amyotrophic lateral sclerosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100913-PIP01-23	mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100797-PIP01-22	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)	Prevention of influenza disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100789-PIP01-22	Fazirsiran	Treatment of congenital alpha-1 antitrypsin deficiency	Not available at present	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024

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