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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100283-PIP01-21-M02 (update)	USTEKINUMAB	Treatment of Crohn's disease	Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100817-PIP01-22-M01 (update)	SIPONIMOD	Treatment of Multiple Sclerosis		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100815-PIP01-22-M01 (update)	SIPONIMOD	Treatment of Multiple Sclerosis	Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Kiendra Mayzent Mayzent Mayzent Kiendra Mayzent Kiendra Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent Kiendra Mayzent Mayzent Mayzent Mayzent Mayzent Mayzent	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100711-PIP01-22-M01 (update)	TISAGENLECLEUCEL	Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma	Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion Kymriah Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100361-PIP01-21-M02 (update)	GOLIMUMAB	Treatment of ulcerative colitis	Simponi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100335-PIP01-21-M01 (update)	Erdafitinib	Treatment of all conditions included in the category of malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue neoplasm)	BALVARSA BALVERSA ERFANDEL tablet BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100114-PIP01-21-M01 (update)	BARICITINIB	Treatment of coronavirus disease 2019 (COVID-19)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100642-PIP01-22-M01 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100641-PIP01-22-M01 (update)	DURVALUMAB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)	IMFINZI IMFINZI IMFINZI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100674-PIP01-22-M01 (update)	DARATUMUMAB	Treatment of lymphoid malignancies (except mature B-cell neoplasms)	Darzalex Darzalex	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100646-PIP01-22-M01 (update)	TOLVAPTAN	Treatment of dilutional hyponatraemia Treatment of polycystic kidney disease	Samsca Jinarc Samsca Jinarc	Uro-Nephrology Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100618-PIP01-22-M01 (update)	AVIBACTAM CEFTAZIDIME	Treatment of intra-abdominal infections Treatment of urinary tract infections Treatment of pneumonia Treatment of infections due aerobic Gram-negative organisms.	Zavicefta	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100550-PIP01-22-M01 (update)	BELIMUMAB	Treatment of systemic lupus erythematosus	Benlysta Benlysta Benlysta Benlysta Benlysta Benlysta	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100547-PIP01-22-M01 (update)	PEGINTERFERON BETA-1A	Treatment of multiple sclerosis	Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100117-PIP01-21-M02 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100068-PIP01-21-M01 (update)	VEDOLIZUMAB	Treatment of Pouchitis	Entyvio Entyvio	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100669-PIP01-22-M01 (update)	EMTRICITABINE RILPIVIRINE TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of Human immunodeficiency virus (HIV-1) infection	Odefsey Odefsey Odefsey Odefsey	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100657-PIP01-22-M01 (update)	BULEVIRTIDE	Treatment of chronic hepatitis D infection	Hepcludex Hepcludex Myrcludex B	Gastroenterology-Hepatology Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100627-PIP01-22-M01 (update)	Liposomal ciclosporin A (L-CsA)	Treatment of bronchiolitis obliterans syndrome (BOS)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023
MHRA-100586-PIP01-22-M01 (update)	DUPILUMAB	Treatment of asthma	Dupixent Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/05/2023

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