PIP Search Page

Displaying 241 - 260 of 284

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100179-PIP01-21	vemircopan	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100179-PIP01-21	vemircopan	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100196-PIP01-21	SARS-CoV-2 virus, beta-propiolactone inactivated	Prevention of coronavirus disease 2019 (COVID-19)	Not available	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100232-PIP01-21	ALECTINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	Alecensa Alecensa	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100140-PIP01-21	BENRALIZUMAB	Treatment of Hypereosinophilic syndrome (HES)	FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100106-PIP01-21	3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde sodium chloride solution 4.2% (w/v)	Treatment of primary ciliary dyskinesia		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100150-PIP01-21	AZITHROMYCIN	Prevention of bronchopulmonary dysplasia (BPD)		Pneumology - Allergology Neonatology - Paediatric Intensive Care	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100050-PIP01-21	efgartigimod alfa	Treatment of Immune thrombocytopenia		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100196-PIP01-21	SARS-CoV-2 virus, beta-propiolactone inactivated	Prevention of coronavirus disease 2019 (COVID-19)	Not available	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100279-PIP01-21	Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No	04/05/2022
MHRA-100339-PIP01-21	Autologous selected renal cells	Treatment of Chronic Kidney Disease	Not available at present	Uro-Nephrology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	04/05/2022
MHRA-100164-PIP01-21	(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	18/03/2022
MHRA-100163-PIP01-21	Vupanorsen (PF-07285557)	Treatment of Hypertriglyceridemia Prevention of cardiovascular events	Not available at present	Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100155-PIP01-21	efgartigimod alfa	Treatment of Chronic Inflammatory Demyelinating Polyneuropathy		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100107-PIP01-21	1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate	Treatment of polycythaemia vera		Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100112-PIP01-21	savolitinib	Treatment of renal neoplasms	Not available	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
MHRA-100054-PIP01-21	RO7496998 (AT-527)	Treatment of coronavirus disease 2019 (COVID-19)	Not available at present	Infectious diseases Other: Pandemic	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	18/03/2022
MHRA-100060-PIP01-21	2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA	Treatment of Duchenne muscular dystrophy		Other: Neuromuscular	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100057-PIP01-21	BENRALIZUMAB	Treatment of eosinophilic oesophagitis	FASENRA FASENRA FASENRA FASENRA	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022
MHRA-100056-PIP01-21	BENRALIZUMAB	Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE)	FASENRA FASENRA FASENRA	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/03/2022

Download XLSX

Search Filters: