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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-100608-PIP01-22-M01 (update)	mitapivat	Treatment of pyruvate kinase deficiency	PYRUKYND PYRUKYND	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100213-PIP01-21-M03 (update)	RAVULIZUMAB	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)	Ultomiris	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100214-PIP01-21-M03 (update)	RAVULIZUMAB	atypical haemolytic uremic syndrome (aHUS)		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100816-PIP01-22-M01 (update)	crovalimab	Treatment of paroxysmal nocturnal haemoglobinuria Treatment of atypical haemolytic uremic syndrome		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100823-PIP01-22-M01 (update)	Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)	Treatment of thrombotic thrombocytopenic purpura	rADAMTS13	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/08/2023
MHRA-100465-PIP01-22-M02 (update)	efanesoctocog alfa	Treatment of congenital haemophilia A		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		19/12/2023
MHRA-100992-PIP01-23-M01 (update)	danicopan	Treatment of paroxysmal nocturnal haemoglobinuria	Voydeya	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100523-PIP01-22-M01 (update)	gadopiclenol	Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity	Not available at present	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100524-PIP01-22-M01 (update)	gadopiclenol	Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity	Not available at present	Diagnostic	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	07/12/2022
MHRA-100064-PIP01-21-M01 (update)	Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid	Prevention of invasive meningococcal disease	MenQuadfi MenQuadfi	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		03/11/2021
MHRA-100237-PIP01-21-M01 (update)	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage) Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)	Prevention of influenza infection	Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe) Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Efluelda Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		29/07/2022
MHRA-100197-PIP01-21-M01 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	27/09/2022
MHRA-100502-PIP01-22-M01 (update)	Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype) Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype) Recombinant Influenza Hemagglutinin-strain B (Victoria lineage) Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)	Prevention of influenza infection	Supemtek Supemtek	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		07/12/2022
MHRA-100177-PIP01-21-M02 (update)	INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN	Prevention of Influenza	FLUCELVAX TETRA Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	24/08/2023
MHRA-100236-PIP01-21-M03 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Prevention of disease caused by Streptococcus pneumoniae	Apexxnar Prevnar 20 Apexxnar	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100932-PIP01-23-M02 (update)	Defatted powder of peanuts	Treatment of peanut allergy	Palforzia Palforzia Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100989-PIP01-23-M01 (update)	DERMATOPHAGOIDES FARINAE DERMATOPHAGOIDES PTERONYSSINUS	Treatment of asthma Treatment of allergic rhinitis	ACARIZAX and associated names ACARIZAX ACARIZAX ACARIZAX ACARIZAX AMITEND ACARIZAX AITARO ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACCARIZAX	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-100214-PIP01-21-M01 (update)	RAVULIZUMAB	Treatment of atypical Haemolytic Uremic Syndrome	Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris Ultomiris	Uro-Nephrology Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022
MHRA-100046-PIP01-21-M01 (update)	cenobamate	Treatment of epilepsy	ONTORZY Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100248-PIP01-21-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/05/2022

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