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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-101028-PIP01-23-M01 (update)	Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)	Prevention of cholera	Vaxchora	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100642-PIP01-22-M02 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO Tremelimumab AstraZeneca	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-101004-PIP01-23-M01 (update)	APIXABAN	Treatment of venous thromboembolism	Eliquis Eliquis Eliquis Eliquis	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100949-PIP01-23-M01 (update)	Delandistrogene moxeparvovec	Treatment of Duchenne muscular dystrophy	Not available	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100482-PIP01-22-M01 (update)	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick disease type C	Not available at present	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100141-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA FASENRA PEN	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101117-PIP01-23-M01 (update)	ORITAVANCIN	Treatment of acute bacterial skin and skin structure infections (ABSSSI)	Tenkasi Tenkasi Orbactiv Tenkasi Tenkasi	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-101188-PIP01-23-M01 (update)	fosdenopterin	Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A	Nulibry	Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101071-PIP01-23-M01 (update)	pegzilarginase	Treatment of hyperargininaemia	Loargys	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100606-PIP01-22-M01 (update)	sparsentan	Treatment of focal segmental glomerulosclerosis	Filspari Filspari	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100253-PIP01-21-M01 (update)	Zuranolone	Treatment of post-partum depression		Psychiatry	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100043-PIP01-21-M01 (update)	zilucoplan	Treatment of myasthenia gravis	Zilbrysq Zilqivik	Neurology Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100473-PIP01-22-M01 (update)	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	SKYCovion	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100992-PIP01-23-M01 (update)	danicopan	Treatment of paroxysmal nocturnal haemoglobinuria	Voydeya	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100982-PIP01-23-M01 (update)	pegunigalsidase alfa	Treatment of Fabry disease	Elfabrio	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100975-PIP01-23-M01 (update)	ERENUMAB	Prevention of migraine headaches	Aimovig Aimovig Aimovig	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100470-PIP01-22-M01 (update)	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100235-PIP01-21-M02 (update)	Sotrovimab	Treatment of coronavirus disease 2019 (COVID-19)	Xevudy Xevudy Xevudy Xevudy Xevudy Xevudy Xevudy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100986-PIP01-23-M01 (update)	ENCORAFENIB	Treatment of melanoma	Braftovi Braftovi Bravtovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100985-PIP01-23-M01 (update)	BINIMETINIB	Treatment of melanoma	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023

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