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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100175-PIP01-21-M01 (update)	AGOMELATINE	Treatment of major depressive episodes	Valdoxan Valdoxan	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100166-PIP01-21-M01 (update)	ENTRECTINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek Rozlytrek	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100170-PIP01-21-M01 (update)	CANAGLIFLOZIN HEMIHYDRATE	Treatment of Type 2 Diabetes Mellitus	Invokana	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100145-PIP01-21-M01 (update)	BRIGATINIB	Non small cell lung cancer Anaplastic large cell lymphoma Inflammatory myofibroblastic tumours	Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig Alunbrig	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100123-PIP01-21-M01 (update)	SARILUMAB	Treatment of chronic idiopathic arthritis	Kevzara Kevzara Kevzara Kevzara Kevzara	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100117-PIP01-21-M01 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100143-PIP01-21-M01 (update)	TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of chronic viral hepatitis B	Vemlidy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100129-PIP01-21-M01 (update)	Cipaglucosidase alfa	Treatment of glycogen storage disease Type II (Pompe's disease)	Pombiliti	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100130-PIP01-21-M01 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100058-PIP01-21-M01 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100046-PIP01-21-M02 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100037-PIP01-21-M01 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/disfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100224-PIP01-21	Etrasimod L-arginine	Treatment of ulcerative colitis	Not available at present	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		29/07/2022
MHRA-100195-PIP01-21-M01 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/05/2022
MHRA-100426-PIP01-22-M01 (update)	ligelizumab	Treatment of chronic spontaneous urticaria		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100412-PIP01-22-M01 (update)	vadadustat	Treatment of anaemia due to chronic disorders	VAFSEO VAFSEO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100342-PIP01-21-M01 (update)	arimoclomol citrate	Treatment of Niemann-Pick Disease, type C	MIPLYFFA	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100327-PIP01-21-M01 (update)	SELPERCATINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Retsevmo Retsevmo Retevmo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100320-PIP01-21-M01 (update)	REMDESIVIR	Treatment of coronavirus disease 2019 (COVID-19)	VEKLURY VEKLURY VEKLURY	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022
MHRA-100264-PIP01-21-M01 (update)	spesolimab	Treatment of Generalised Pustular Psoriasis Prevention of Generalised Pustular Psoriasis		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/05/2022

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