PIP Search Page

Displaying 501 - 520 of 669

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-100848-PIP01-23	messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene	Treatment for transthyretin amyloidosis (ATTR)	Not available at present	Neurology Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100829-PIP01-22	Edaravone	Treatment of Amyotrophic lateral sclerosis	Not available at this moment	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100301-PIP04-23	Nipocalimab	Treatment of chronic inflammatory demyelinating polyradiculoneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-101023-PIP01-23-M01 (update)	ganaxolone	Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder	ZTALMY ZTALMY	Neurology	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-100975-PIP01-23-M01 (update)	ERENUMAB	Prevention of migraine headaches	Aimovig Aimovig Aimovig	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100043-PIP01-21-M01 (update)	zilucoplan	Treatment of myasthenia gravis	Zilbrysq Zilqivik	Neurology Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100482-PIP01-22-M01 (update)	acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)	Treatment of Niemann-Pick disease type C	Not available at present	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100949-PIP01-23-M01 (update)	Delandistrogene moxeparvovec	Treatment of Duchenne muscular dystrophy	Not available	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-101016-PIP01-23	ublituximab	Treatment of multiple sclerosis	Briumvi Briumvi	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	20/12/2023
MHRA-100336-PIP01-21-M02 (update)	Soticlestat	Treatment of Dravet Syndrome Treatment of Lennox-Gastaut Syndrome		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-100547-PIP01-22-M02 (update)	PEGINTERFERON BETA-1A	Treatment of multiple sclerosis.	Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy Plegridy	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/01/2024
MHRA-101030-PIP01-23	Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIPK1) (SAR443820)	Treatment of Amyotrophic lateral sclerosis		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-101287-PIP01-23	SUMATRIPTAN NAPROXEN SODIUM	Treatment of migraine headaches	Suvexx 85 mg/500 mg film-coated tablets FI, DK, HU, NO, SE: Nomigrin EE, LT, LV: Migsun PL: Frimig Duo	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100594-PIP01-22	N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide	Treatment of focal onset seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-100103-PIP01-21	Rozanolixizumab	Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease	Not available at present	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/04/2024
MHRA-101115-PIP01-23	Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)	Treatment of Amyotrophic lateral sclerosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100462-PIP01-22-M02 (update)	FENFLURAMINE HYDROCHLORIDE	Treatment of Dravet Syndrome	Fintepla Fintepla Fintepla Fintepla Fintepla	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100468-PIP01-22-M02 (update)	EPTINEZUMAB	Prevention of migraine headaches	Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti Vyepti	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024
MHRA-100046-PIP01-21-M04 (update)	cenobamate	Treatment of epilepsy	Ontozry Ontozry Xcopri Ontozry	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/04/2024

Download XLSX

Search Filters: