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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
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-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-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-100214-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of atypical Haemolytic Uremic Syndrome	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100605-PIP01-22	sparsentan	Treatment of immunoglobulin A nephropathy	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100046-PIP01-21-M01 (update)	cenobamate	Treatment of epilepsy	ONTORZY Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100248-PIP01-21-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100445-PIP01-22	RAVULIZUMAB	Treatment of Neuromyelitis Optica Spectrum Disorder	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		07/12/2022
MHRA-100743-PIP01-22-M01 (update)	efgartigimod alfa	Treatment of generalised myasthenia gravis	Vyvgart Vyvgart Vyvgart	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	02/02/2023
MHRA-100610-PIP01-22-M01 (update)	ECULIZUMAB	Treatment of myasthenia gravis	SOLIRIS SOLIRIS	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100706-PIP01-22	METHYLPHENIDATE HYDROCHLORIDE	Treatment of attention-deficit hyperactivity disorder	Not available at present Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride Methylphenidate hydrochloride	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		30/06/2023
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-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-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-100039-PIP01-21-M01 (update)	Cotadutide	Treatment of non-alcoholic steatohepatitis (NASH)		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021
MHRA-100068-PIP01-21	VEDOLIZUMAB	Treatment of Pouchitis	Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio; Kynteles Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Entyvio Kynteles Entyvio Entyvio Entyvio Entyvio	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes		17/03/2022
MHRA-100224-PIP01-21-M01 (update)	Etrasimod L-arginine	Treatment of ulcerative colitis		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	25/05/2023
MHRA-100775-PIP01-22-M01 (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)	maralixibat chloride	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	01/08/2023
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

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