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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-100599-PIP01-22	Flortaucipir F18	Diagnosis of Alzheimer's disease	Tauvid Tauvid	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100126-PIP01-21-M01 (update)	Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene	Duchenne Muscular Dystrophy	fordadistrogene movaparvovec	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		15/06/2023
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-100709-PIP01-22-M02 (update)	Rozanolixizumab	Treatment of myasthenia gravis		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100709-PIP01-22-M01 (update)	rozanolixizumab	Treatment of myasthenia gravis		Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100699-PIP01-22-M01 (update)	DIROXIMEL FUMARATE	Treatment of Multiple Sclerosis	Vumerity Vumerity Vumerity	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/06/2023
MHRA-100717-PIP01-22-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100118-PIP02-22	OCRELIZUMAB	Treatment of Multiple Sclerosis	Ocrevus Ocrevus Ocrevus	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/08/2023
MHRA-100807-PIP01-22-M01 (update)	RIMEGEPANT SULFATE	Treatment of migraine headaches	Vydura	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		24/08/2023
MHRA-100801-PIP01-22	eplontersen	Treatment of transthyretin-mediated amyloidosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/08/2023
MHRA-100299-PIP01-21	Humanized monoclonal IgG1-based antibody	Treatment of spinal muscular atrophy	Not available at present	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
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-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-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-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-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

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