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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-100909-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of Ewing's sarcoma.	Verzenios Verzenios Verzenios	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100910-PIP01-23-M01 (update)	ABEMACICLIB	Treatment of glioma Treatment of neuroblastoma	Verzenios Verzenios Verzenios	Oncology	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-100524-PIP01-22-M02 (update)	gadopiclenol	Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes	Elucirem Elucirem	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100523-PIP01-22-M02 (update)	gadopiclenol	Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.	Elucirem Elucirem	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100352-PIP01-21-M02 (update)	AVAPRITINIB	Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100579-PIP01-22-M03 (update)	Maribavir	Treatment of cytomegalovirus (CMV) infection	Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtencity Livtenicty Livtencity Livtencity Livtencity	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100066-PIP01-21-M01 (update)	efgartigimod alfa	Treatment of myasthenia gravis	Vyvgart Vyvgart Vyvgart	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100443-PIP01-22-M02 (update)	BARICITINIB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100075-PIP01-21-M02 (update)	leniolisib	Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)	Joenja Joenja Joenja Joenja	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100818-PIP01-22-M01 (update)	BEMPEDOIC ACID	Treatment of elevated cholesterol	Nilemdo® (bempedoic acid) tablets Nilemdo® (bempedoic acid) film-coated tablets Nilemdo® (bempedoic acid) film-coated tablets Nexletol® (bempedoic acid) tablets Nilemdo® Nilemdo® Nilemdo® Nexletol® Nilemdo®	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100907-PIP01-23-M01 (update)	CEFTOLOZANE TAZOBACTAM	Treatment of pneumonia	ZERBAXA ZERBAXA ZERBAXA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100149-PIP01-21-M02 (update)	NVX-CoV2373	Prevention of coronavirus disease 2019 (COVID-19)	Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted) Nuvaxovid Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100050-PIP01-21-M01 (update)	efgartigimod alfa	Treatment of immune thrombocytopenia.	Vyvgart Vyvgart	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100931-PIP01-23-M01 (update)	mirikizumab	Treatment of ulcerative colitis Treatment of Crohn's disease		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	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
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-100343-PIP01-21-M02 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension Treatment of systemic sclerosis Treatment of idiopathic pulmonary fibrosis	Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023

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