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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100445-PIP01-22-M01 (update)
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100214-PIP01-21-M04 (update)
  • RAVULIZUMAB
  • Treatment of atypical haemolytic uremic syndrome.
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomriris
  • Ultomriris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100213-PIP01-21-M04 (update)
  • RAVULIZUMAB
  • Treatment of Paroxysmal Nocturnal Haemoglobinuria
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100120-PIP01-21-M01 (update)
  • TOCILIZUMAB
  • Treatment of Coronavirus disease 2019 (COVID 19)
  • RoActemra
  • RoActemra
  • Infectious diseases
  • Other: COVID 19 Pandemic
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-100348-PIP01-21-M01 (update)
  • botaretigene sparoparvovec
  • Treatment of retinitis pigmentosa
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100818-PIP01-22-M02 (update)
  • BEMPEDOIC ACID
  • Treatment of elevated cholesterol
  • Nilemdo® (bempedoic acid) tablets
  • Nilemdo®
  • Nilemdo®
  • Nexletol®
  • Nilemdo®
  • Nilemdo®
  • Nilemdo®
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-101238-PIP01-23-M01 (update)
  • UPADACITINIB
  • Treatment of ulcerative colitis
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-101198-PIP01-23-M01 (update)
  • RISANKIZUMAB
  • Treatment of Crohn's disease
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100469-PIP01-22-M02 (update)
  • delgocitinib
  • Treatment of chronic hand eczema
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/06/2024
MHRA-100377-PIP01-21-M02 (update)
  • ACALABRUTINIB
  • Treatment of mature B cell neoplasms
  • calquence
  • calquence
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-100167-PIP01-21-M02 (update)
  • SODIUM ZIRCONIUM CYCLOSILICATE
  • Treatment of hyperkalaemia
  • Lokelma
  • Lokelma
  • Lokelma
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100167-PIP01-21-M02 (update)
  • SODIUM ZIRCONIUM CYCLOSILICATE
  • Treatment of hyperkalaemia
  • Lokelma
  • Lokelma
  • Lokelma
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-100719-PIP01-22-M01 (update)
  • LUTETIUM (177LU) OXODOTREOTIDE
  • Treatment of gastroenteropancreatic neuroendocrine tumours
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100392-PIP01-21-M04 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
  • TOZINAMERAN
  • FAMTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100258-PIP01-21-M02 (update)
  • Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-101268-PIP01-23
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1
  • Prevention of pandemic influenza
  • Incellipan
  • Audenz
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 24/06/2024
MHRA-101264-PIP01-23
  • cemdisiran
  • Treatment of myasthenia gravis
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101264-PIP01-23
  • cemdisiran
  • Treatment of myasthenia gravis
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101263-PIP01-23
  • pozelimab
  • Treatment of myasthenia gravis
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-100363-PIP01-21
  • Repagermanium
  • Treatment of focal segmental glomerulosclerosis (FSGS)
  • Uro-Nephrology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
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