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Displaying 1001 - 1020 of 1097

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100275-PIP01-21	SEMAGLUTIDE	Treatment of non-alcoholic steatohepatitis (NASH)	Ozempic OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Ozempic Ozempic Ozempic Ozempic OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100208-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of non-alcoholic steatohepatitis		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100230-PIP01-21	Thienopyrimidine Derivative	Treatment of fibrosing interstitial lung disease		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100254-PIP01-21	epcoritamab	Treatment of mature B-cell malignancies	Not available at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100291-PIP01-21	imetelstat	Treatment of acute myeloid leukaemia Treatment of Myelodysplastic Syndromes (MDS), including JMML		Oncology	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-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-100053-PIP01-21-M01 (update)	IMDEVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	04/05/2022
MHRA-100052-PIP01-21-M01 (update)	CASIRIVIMAB	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Ronapreve Ronapreve Ronapreve Ronapreve	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	04/05/2022
MHRA-100276-PIP01-21-M01 (update)	BRODALUMAB	Treatment of psoriasis	brodalumab Lumicef Siliq Kyntheum	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	04/05/2022
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-100390-PIP01-21-M01 (update)	Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)	Prevention of coronavirus disease 2019 (COVID-19)	Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/04/2022

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