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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100472-PIP01-22	Tarlatamab	Treatment of small cell lung cancer (SCLC) Treatment of prostate malignant neoplasms.		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/02/2023
MHRA-100251-PIP01-21	DUPILUMAB	Chronic pruritus of unknown origin	Dupixent Dupixent Dupixent Dupixent Dupixent	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/02/2023
MHRA-100451-PIP01-22-M02 (update)	fidanacogene elaparvovec	Treatment of congenital factor IX deficiency (haemophilia B)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100451-PIP01-22-M01 (update)	fidanacogene elaparvovec	Treatment of congenital factor IX deficiency (haemophilia B)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100025-PIP01-21-M02 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100499-PIP01-22-M01 (update)	Giroctocogene Fitelparvovec	Treatment of haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023
MHRA-100405-PIP01-21-M01 (update)	LIRAGLUTIDE	Treatment of obesity	Saxenda Saxenda Saxenda	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
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-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-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-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-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-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-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-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-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-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-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-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

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