PIP Search Page

Displaying 681 - 700 of 773

PIPS Search Results
PIP Number	Active Substance Sort descending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100066-PIP01-21-M01 (update)	efgartigimod alfa	Treatment of myasthenia gravis	Vyvgart Vyvgart Vyvgart	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100910-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of glioma Treatment of neuroblastoma	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100909-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of Ewing's sarcoma.	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100469-PIP01-22-M01 (update)	delgocitinib	Treatment of chronic hand eczema		Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100993-PIP01-23-M01 (update)	QUIZARTINIB DIHYDROCHLORIDE	Treatment of acute myeloid leukaemia (AML)	VANFLYTA VANFLYTA VANFLYTA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100079-PIP01-21-M02 (update)	GILTERITINIB FUMARATE	Treatment of acute myeloid leukemia	Xospata Xospata	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100079-PIP01-21-M03 (update)	GILTERITINIB FUMARATE	Treatment of acute myeloid leukaemia (AML)	Xospata Xospata	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-101006-PIP01-23-M01 (update)	IMLIFIDASE	Prevention of graft rejection following solid organ transplantation	Idefirix Idefirix Idefirix Idefirix Idefirix	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100625-PIP01-22-M01 (update)	RISANKIZUMAB	Treatment of psoriasis	Skyrizi Skyrizi Skyrizi Skyrizi	Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100951-PIP01-23-M01 (update)	FOSTEMSAVIR TROMETHAMINE	Treatment of human immunodeficiency virus (HIV-1) infection	RUKOBIA RUKOBIA RUKOBIA RUKOBIA Rukobia 600 mg prolonged-release tablets	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100951-PIP01-23-M02 (update)	FOSTEMSAVIR TROMETHAMINE	Treatment of human immunodeficiency virus (HIV-1) infection	RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA RUKOBIA Rukobia 600 mg prolonged-release tablets	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100934-PIP01-23-M01 (update)	CARFILZOMIB	Treatment of acute lymphoblastic leukaemia	Kyprolis Kyprolis Kyprolis Kyprolis	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100921-PIP01-23-M01 (update)	AVATROMBOPAG	Treatment of Idiopathic Thrombocytopenia Purpura Treatment of Thrombocytopenic Purpura Secondary to Liver Disease	Doptelet Avatrombopag	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101149-PIP01-23-M01 (update)	elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)	Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)	Vimizim 1mg/ml concentrate for solution for infusion	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100985-PIP01-23-M01 (update)	BINIMETINIB	Treatment of melanoma	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100985-PIP02-23	BINIMETINIB	Treatment of lung cancer	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100986-PIP01-23-M01 (update)	ENCORAFENIB	Treatment of melanoma	Braftovi Braftovi Bravtovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100986-PIP02-23	ENCORAFENIB	Treatment of lung cancer	Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100470-PIP01-22-M01 (update)	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100975-PIP01-23-M01 (update)	ERENUMAB	Prevention of migraine headaches	Aimovig Aimovig Aimovig	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023

Download XLSX