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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 descending
MHRA-100775-PIP01-22-M02 (update)	(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride Maralixibat chloride	Treatment of Alagille Syndrome (ALGS)	Livmarli (maralixibat chloride) LIVMARLI	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	01/08/2023
MHRA-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100844-PIP01-23-M01 (update)	IVACAFTOR	Treatment of cystic fibrosis.	Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco Kalydeco	Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	24/08/2023
MHRA-100332-PIP01-21-M01 (update)	sotatercept	Treatment of pulmonary arterial hypertension	Not available at present	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		24/08/2023
MHRA-100720-PIP01-22-M02 (update)	Gepotidacin	Treatment of uncomplicated urinary tract infection	Not available at present	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100823-PIP01-22-M01 (update)	Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)	Treatment of thrombotic thrombocytopenic purpura	rADAMTS13	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/08/2023
MHRA-100741-PIP01-22	CRISANTASPASE	Treatment of acute lymphoblastic leukaemia Treatment of lymphoblastic lymphoma	Enrylaze Rylaze	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100787-PIP01-22	Repotrectinib	Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)	Not available at present	Oncology Other: Not Applicable	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		19/12/2023
MHRA-100885-PIP01-23	Iptacopan	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)	Not available at present; Product code: LNP023	Haematology-Hemostaseology Other: Complement-driven renal disease	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100465-PIP01-22-M02 (update)	efanesoctocog alfa	Treatment of congenital haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		19/12/2023
MHRA-100098-PIP01-21-M02 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100099-PIP01-21-M03 (update)	BRIVARACETAM	Treatment of paediatric epilepsy syndromes Treatment of neonatal seizures	Briviact (in Italy: Nubriveo) Briviact Briviact Briviact Briviact	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100865-PIP01-23-M01 (update)	RILPIVIRINE	Treatment of human immunodeficiency virus (HIV-1) infection	REKAMBYS	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100195-PIP01-21-M03 (update)	BALOXAVIR MARBOXIL	Treatment of Influenza Prevention of Influenza	Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza Xofluza	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-101023-PIP01-23-M02 (update)	ganaxolone	Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder		Neurology	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-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-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-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-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

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