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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100579-PIP01-22-M01 (update)	Maribavir	Treatment of cytomegalovius (CMV) infection	Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100579-PIP01-22-M02 (update)	Maribavir	Treatment of cytomegalovius (CMV) infection	Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100093-PIP01-21-M02 (update)	UPADACITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100118-PIP01-21-M02 (update)	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100471-PIP01-22-M01 (update)	SETMELANOTIDE	Treatment of appetite and general nutrition disorders	IMCIVREE IMCIVREE IMCIVREE IMCIVREE	Nutrition	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100406-PIP01-21-M01 (update)	Marstacimab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100636-PIP01-22-M01 (update)	Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain	Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV)			PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100648-PIP01-22-M01 (update)	TECOVIRIMAT MONOHYDRATE	Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)	Tecovirimat SIGA Tecovirimat SIGA TPOXX	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100023-PIP01-21-M02 (update)	bimekizumab	Treatment of psoriasis	Bimzelx Bimzelx Bimzelx	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100031-PIP01-21-M02 (update)	PALBOCICLIB	Treatment of Ewing sarcoma (EWS)	Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance Ibrance blisters in an outer carton/21 and 63 tablets Ibrance	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100289-PIP01-21-M02 (update)	GALCANEZUMAB	Prevention of migraine headache	Emgality Emgality Emgality Emgality Emgality Emgality Emgality	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100369-PIP01-21-M01 (update)	MIGALASTAT HYDROCHLORIDE	Treatment of Fabry disease	Galafold Galafold Galafold 123 mg capsules	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100442-PIP01-22-M01 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100695-PIP01-22-M02 (update)	Etranacogene dezaparvovec	Treatment of haemophilia B	Hemgenix	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100169-PIP01-21-M01 (update)	BETIBEGLOGENE AUTOTEMCEL	Treatment of beta-thalassaemia	zynteglo	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100225-PIP01-21-M01 (update)	recombinant parathyroid hormone	Treatment of hypoparathyroidism	Natpar Natpar	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100440-PIP01-22-M01 (update)	BICTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE	Treatment of Human immunodeficiency virus (HIV-1) infection	Biktarvy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100462-PIP01-22-M01 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet syndrome	Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100467-PIP01-22-M01 (update)	SEMAGLUTIDE	Treatment of obesity	Ozempic Ozempic 0.25 mg, 0.5 mg, 1 mg	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100468-PIP01-22-M01 (update)	EPTINEZUMAB	Prevention of migraine headaches	Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023

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