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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-100593-PIP01-22	aticaprant	Treatment of Major Depressive Disorder	Not available at present	Psychiatry	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	30/01/2024
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-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-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-100027-PIP01-21	benzylamine derivative of benzofuran	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100091-PIP01-21	Rozanolixizumab	Treatment of Immune thrombocytopenia	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100266-PIP01-21	Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene	Treatment of sickle cell disease		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100267-PIP01-21	Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene	Treatment of beta-thalassemia intermedia and major		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100372-PIP01-21	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100559-PIP01-22	mitapivat	Treatment of thalassaemia	PYRUKYND PYRUKYND	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100635-PIP01-22	CEDAZURIDINE DECITABINE	Treatment of acute myeloid leukaemia	INQOVI INQOVI Inqovi 35/100 INAQOVI	Haematology-Hemostaseology Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	25/05/2023
MHRA-100824-PIP01-22	perflubutane	Diagnostic evaluation of focal hepatic lesions	Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid Sonazoid	Diagnostic Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	24/08/2023
MHRA-100038-PIP01-21	Recombinant protein derived from the SARS CoV2 prefusion Spike delta TM protein adjuvanted with AS03	Prevention of Covid-19	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	03/11/2021
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-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-100364-PIP01-21	Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01	Prevention of lower respiratory tract disease caused by respiratory syncytial virus	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100473-PIP01-22	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100470-PIP01-22	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100239-PIP01-21	multivalent pneumococcal polysaccharide conjugate vaccine	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022

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