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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort ascending	Decision Type	Compliance Check	Date Published
MHRA-100309-PIP01-21	gantenerumab	Prevention of Alzheimer's disease	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100301-PIP01-21	Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab )	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100316-PIP01-21	latozinemab	Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100037-PIP01-21-M01 (update)	ponesimod	Treatment of Multiple Sclerosis	Ponvory	Neurology Other: Autoimmune disease/disfunction	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100046-PIP01-21-M02 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100289-PIP01-21-M01 (update)	GALCANEZUMAB	Prevention of migraine headaches	Emgality Emgality Emgality	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100336-PIP01-21-M01 (update)	soticlestat	Treatment of Dravet Syndrome Lennox-Gastaut Syndrome		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100105-PIP01-21	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100151-PIP01-21	CANNABIDIOL	Treatment of epilepsy with myoclonic-atonic seizures (EMAS)	Epidyolex Epidyolex Epidyolex Epidiolex Epidyolex Epidyolex Epidiolex	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100382-PIP01-21	RAVULIZUMAB	Treatment of myasthenia gravis	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100374-PIP01-21	Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene	Treatment of frontotemporal dementia		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100185-PIP01-21	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of cold agglutinin disease		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100355-PIP02-22	Fenebrutinib	Treatment of multiple sclerosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100441-PIP01-22-M01 (update)	Delandistrogene moxeparvovec	Treatment of Duchenne Muscular Dystrophy (DMD)	Elevidys	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100476-PIP01-22	Anti-(alpha-synuclein) human monoclonal antibody	Treatment of Multiple System Atrophy Treatment of Parkinson's Disease		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100135-PIP02-22	anti-CD40L humanised monoclonal antibody (SAR441344)	Treatment of progressive Multiple Sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100556-PIP01-22	Anti-C1s Humanized IgG4 Monoclonal Antibody	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology Immunology -Rheumatology-Transplantation Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100574-PIP01-22	lixmabegagene relduparvovec	Treatment of GM1 gangliosidosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100482-PIP01-22	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick Disease type C (NPC)		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/02/2023
MHRA-100087-PIP01-21-M02 (update)	LACOSAMIDE	Treatment of generalised epilepsy and epileptic syndromes.		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/02/2023

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