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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100175-PIP01-21-M01 (update)
  • AGOMELATINE
  • Treatment of major depressive episodes
  • Valdoxan
  • Valdoxan
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 29/07/2022
MHRA-100515-PIP01-22-M01 (update)
  • VORTIOXETINE
  • Treatment of Major Depressive Disorder
  • Brintellix
  • Brintellix
  • Brintellix
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/06/2023
MHRA-100213-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of Paroxysmal Nocturnal Haemoglobinuria
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100412-PIP01-22-M01 (update)
  • vadadustat
  • Treatment of anaemia due to chronic disorders
  • VAFSEO
  • VAFSEO
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/05/2022
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-100885-PIP01-23
  • Iptacopan
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Not available at present; Product code: LNP023
  • Haematology-Hemostaseology
  • Other: Complement-driven renal disease
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 19/12/2023
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-100021-PIP01-21
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 03/11/2021
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
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