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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-101538-PIP01-24	NIVOLUMAB relatlimab	Treatment of melanoma	Opdualag Opdualag Opdualag Opdualag Opdualag	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-101543-PIP01-24-M01 (update)	SELUMETINIB HYDROGEN SULFATE	Treatment of neurofibromatosis type 1 Treatment of thyroid cancer Treatment of melanoma	Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo Koselugo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-100317-PIP01-21-M01 (update)	Ralinepag	Treatment of pulmonary arterial hypertension		Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-101525-PIP01-24	Actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)	Treatment of PSMA-expressing prostate cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	06/01/2025
MHRA-101509-PIP01-24	Ferric Citrate Coordination Complex	Treatment of anaemias due to chronic kidney disorders	Xoanacyl Auryxia Riona Nephoxil Nephoxil	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-100352-PIP01-21-M03 (update)	AVAPRITINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-100966-PIP01-23-M01 (update)	Selvacovatein (INN) - SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants) SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer – XBB.1.16-XBB.1.16 variant	Prevention of coronavirus disease 2019 (COVID-19)	Bimervax Bimervax Bimervax Bimervax BIMERVAX BIMERVAX	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-101451-PIP01-24-M01 (update)	Osivelotor	Treatment of sickle cell disease		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-101451-PIP01-24	Osivelotor	Treatment of sickle cell disease		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-100019-PIP01-21-M01 (update)	BELUMOSUDIL MESYLATE	Treatment of chronic Graft versus Host Disease (cGVHD)	Rezurock Rezurock Rholistiq Rholistiq Rezurock Rezurock Rezurock Rezurock Rezurock Rezurock Rezurock Belumosudil	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-101177-PIP01-23	Recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody (navenibart; STAR-0215)	Treatment of hereditary angioedema	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-101167-PIP01-23-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cometriq Cometriq	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-100584-PIP02-23	Live attenuated respiratory syncytial virus (RSV)	Prevention of respiratory syncytial virus (RSV) disease		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-101048-PIP01-23	doruxapapogenum ralaplasmidum	Treatment of recurrent respiratory papillomatosis		Infectious diseases Oto-Rhino-Laryngology Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-100958-PIP01-23	bidridistrogene xeboparvovec	Treatment of Limb-girdle muscular dystrophy		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	06/01/2025
MHRA-100882-PIP01-23-M01 (update)	Glucagon analogue linked to a human immunoglobulin Fc fragment	Treatment of congenital hyperinsulinism		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	06/01/2025
MHRA-101106-PIP01-23	LY3884963 (PR006A)	Treatment of frontotemporal dementia		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	06/01/2025
MHRA-101469-PIP01-24	Garetosmab	Treatment of fibrodysplasia ossificans progressiva (FOP)	FOPSIVVA	Other: Musculoskeletal Disease	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/11/2024
MHRA-100235-PIP01-21-M03 (update)	Sotrovimab	Treatment of coronavirus disease 2019 (COVID-19)	Xevudy Xevudy Xevudy Xevudy Xevudy Xevudy Xevudy Xevudy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/11/2024
MHRA-100222-PIP01-21-M03 (update)	romosozumab	Treatment of osteoporosis	EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY EVENITY 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	29/11/2024

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