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Displaying 41 - 60 of 295

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
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-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-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-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-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-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-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-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-100368-PIP01-21	aumolertinib	Treatment of lung cancer	Ameile	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100381-PIP01-21	Regdanvimab	Treatment of coronavirus disease 2019 (COVID-19)	Regkirona Regkirona Inj.	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100346-PIP01-21	molnupiravir	Prevention of coronavirus disease 2019 (COVID-19)	Lagevrio Lagevrio	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100324-PIP01-21	Loncastuximab tesirine	Treatment of mature B-cell neoplasms	Zynlonta Zynlonta	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100135-PIP01-21	anti-CD40L humanized monoclonal antibody (SAR441344)	Treatment of Sjogren's Syndrome		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100184-PIP01-21	BENRALIZUMAB	Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100204-PIP01-21	verdiperstat	Treatment of Amyotrophic lateral sclerosis	Dazluma	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100194-PIP01-21	sivopixant	Treatment of unexplained or refractory chronic cough		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100206-PIP01-21	EMPAGLIFLOZIN	Treatment of ischaemic heart disease	Jardiance Jardiance	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
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

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