PIP Search Page

Displaying 281 - 300 of 773

PIPS Search Results
PIP Number	Active Substance Sort ascending	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100442-PIP01-22-M02 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
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-100369-PIP01-21-M02 (update)	MIGALASTAT HYDROCHLORIDE	Treatment of Fabry disease	Galafold 123 mg capsules Galafold Galafold	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/01/2024
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-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-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-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-100406-PIP01-21-M02 (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		19/12/2023
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-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-100579-PIP01-22-M03 (update)	Maribavir	Treatment of cytomegalovirus (CMV) infection	Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtenicty Livtencity Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100695-PIP01-22-M01 (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-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-100695-PIP01-22-M04 (update)	Etranacogene dezaparvovec	Treatment of haemophilia B	Hemgenix Hemgenix Hemgenix Hemgenix	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/04/2024
MHRA-100418-PIP01-22-M01 (update)	axicabtagene ciloleucel	Treatment of mature B-cell neoplasms	Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta Yescarta	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		02/02/2023
MHRA-100421-PIP01-22	efavaleukin alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023
MHRA-100503-PIP01-22	efavaleukin alfa	Treatment of ulcerative colitis	Not available at present	Other: Inflammatory Bowel Disease	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		25/05/2023
MHRA-100519-PIP01-22	RSV preF protein	Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)			P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023
MHRA-100519-PIP01-22	RSV preF protein	Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)			P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		02/02/2023

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