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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	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-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-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-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-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
MHRA-100249-PIP01-21-M02 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma	Trixeo Aerosphere Trixeo Aerosphere Trixeo Aerosphere BREZTRI AEROSPHERE	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100625-PIP01-22-M01 (update)	RISANKIZUMAB	Treatment of psoriasis	Skyrizi Skyrizi Skyrizi Skyrizi	Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100409-PIP01-21-M01 (update)	autologous dendritic cells pulsed with autologous tumour cell lysate	Treatment of high grade glioma		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100327-PIP01-21-M02 (update)	SELPERCATINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).	Retsevmo Retsevmo Retevmo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100288-PIP01-21-M02 (update)	DENOSUMAB	Treatment of osteoporosis	Prolia Prolia	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100270-PIP01-21-M01 (update)	crinecerfont	Treatment of congenital adrenal hyperplasia		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-101079-PIP01-23-M01 (update)	ZANUBRUTINIB	Treatment of lymphoplasmacytic lymphoma Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)	Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa Brukinsa	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100758-PIP01-22-M01 (update)	BEZLOTOXUMAB	Prevention of recurrence of Clostridioides difficile infection	ZINPLAVA ZINPLAVA ZINPLAVA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100995-PIP01-23	LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)	Treatment of fibrosing Interstitial Lung Diseases (ILD)		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100301-PIP04-23	Nipocalimab	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023

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