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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-100989-PIP01-23-M01 (update)	DERMATOPHAGOIDES FARINAE DERMATOPHAGOIDES PTERONYSSINUS	Treatment of asthma Treatment of allergic rhinitis	ACARIZAX and associated names ACARIZAX ACARIZAX ACARIZAX ACARIZAX AMITEND ACARIZAX AITARO ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACCARIZAX	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-100442-PIP01-22-M02 (update)	TALIMOGENE LAHERPAREPVEC	Treatment of melanoma	Imlygic Imlygic Imlygic	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/04/2024
MHRA-101094-PIP01-23	Givinostat	Treatment of Duchenne muscular dystrophy		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	30/04/2024
MHRA-101003-PIP01-23-M01 (update)	garadacimab	Prevention of hereditary angioedema		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	06/03/2024
MHRA-101053-PIP01-23-M01 (update)	DOLUTEGRAVIR ABACAVIR LAMIVUDINE	Treatment of human immunodeficiency virus (HIV-1) infection	TRIUMEQ TRIUMEQ	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/01/2024
MHRA-101131-PIP01-23-M01 (update)	BLINATUMOMAB	Treatment of acute lymphoblastic leukaemia	BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCTYO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/01/2024
MHRA-100123-PIP01-21-M02 (update)	SARILUMAB	Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)	Kevzara Kevzara	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/01/2024
MHRA-100117-PIP01-21-M03 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/01/2024
MHRA-101058-PIP01-23	SIROLIMUS	Treatment of Tuberous Sclerosis	Pascomer	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	30/01/2024
MHRA-100991-PIP01-23	Maralixibat chloride	Treatment of progressive familial intrahepatic cholestasis (PFIC)	LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	30/01/2024
MHRA-100162-PIP01-21-M02 (update)	SELEXIPAG	Treatment of pulmonary arterial hypertension (PAH)	Uptravi Uptravi Uptravi	Other: Pulmonary heart disease and diseases of pulmonary circulation	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100932-PIP01-23-M02 (update)	Defatted powder of peanuts	Treatment of peanut allergy	Palforzia Palforzia Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	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-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-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-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-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-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-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-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

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