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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-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-101149-PIP01-23-M01 (update)	elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)	Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)	Vimizim 1mg/ml concentrate for solution for infusion	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
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-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-100901-PIP01-23-M02 (update)	CABOTEGRAVIR	Treatment of human immunodeficiency virus (HIV-1) infection	Vocabria Vocabria / Cabenuva Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria Vocabria / Cabenuva Vocabria / Cabenuva Vocabria	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100236-PIP01-21-M03 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Prevention of disease caused by Streptococcus pneumoniae	Apexxnar Prevnar 20 Apexxnar	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	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-100521-PIP01-22-M02 (update)	Evinacumab	Treatment of elevated cholesterol	Evkeeza Evkeeza Evkeeza Evkeeza Evkeeza Evkeeza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100897-PIP01-23-M01 (update)	Nemolizumab	Treatment of atopic dermatitis	Not yet defined	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		19/12/2023

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