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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100805-PIP01-22-M01 (update)	ATIDARSAGENE AUTOTEMCEL	Treatment of metachromatic leukodystrophy (MLD)	Libmeldy Libmeldy Libmeldy	Other: Lysosomal storage Disorder	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100802-PIP01-22-M01 (update)	roxadustat	Treatment of anaemia due to chronic disorders	EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO EVRENZO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100727-PIP01-22-M01 (update)	ALPELISIB	Treatment of PIK3CA related overgrowth spectrum	Vijoice Piqray Vijoice	Other: Congenital, Hereditary, Neonatal Disease and Abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100716-PIP01-22-M01 (update)	RUXOLITINIB PHOSPHATE	Treatment of chronic Graft versus Host Disease	Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi Jakavi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/06/2023
MHRA-100544-PIP01-22-M01 (update)	sebetralstat	Treatment of hereditary angioedema		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100515-PIP01-22-M01 (update)	VORTIOXETINE	Treatment of Major Depressive Disorder	Brintellix Brintellix Brintellix	Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/06/2023
MHRA-100392-PIP01-21-M03 (update)	TOZINAMERAN TOZINAMERAN/ FAMTOZINAMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100580-PIP01-22-M01 (update)	CEMIPLIMAB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Cemiplimab	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100195-PIP01-21-M02 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100681-PIP01-22	Lomitapide	Treatment of (heterozygous or homozygous) familial hypercholesterolaemia	Lojuxta hard capsule	Other: Hypercholesterolaemia (HoFH)	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100845-PIP01-23-M02 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	N/A VOCABRIA AND APRETUDE Apretude N/A N/A N/A Apretude Apretude	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	20/06/2023
MHRA-100845-PIP01-23-M01 (update)	CABOTEGRAVIR	Prevention of human immunodeficiency virus (HIV-1) infection	VOCABRIA and CABENUVA Apretude APRETUDE Apretude VOCABRIA/APRETUDE	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		20/06/2023
MHRA-100598-PIP01-22	Cobolimab	Treatment of lung cancer	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100587-PIP01-22	lusvertikimab	Treatment of Sjögren’s syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100577-PIP01-22	ziltivekimab	Treatment of heart failure	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100603-PIP01-22	Oleclumab	Treatment of lung cancer Treatment of pancreatic cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100602-PIP01-22	monalizumab	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100583-PIP01-22	SACITUZUMAB GOVITECAN	Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)	Trodelvy Trodelvy Trodelvy	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100599-PIP01-22	Flortaucipir F18	Diagnosis of Alzheimer's disease	Tauvid Tauvid	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100555-PIP01-22	vepsitamab	Treatment of gastric cancer and gastro-oesophageal junction cancer Treatment of colorectal carcinoma Treatment of pancreatic cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023

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