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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101469-PIP01-24
  • Garetosmab
  • Treatment of fibrodysplasia ossificans progressiva (FOP)
  • FOPSIVVA
  • Other: Musculoskeletal Disease
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-100235-PIP01-21-M03 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100222-PIP01-21-M03 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100336-PIP01-21-M03 (update)
  • soticlestat
  • Treatment of Dravet Syndrome. Treatment of Lennox-Gastaut Syndrome.
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100254-PIP01-21-M02 (update)
  • epcoritamab
  • Treatment of mature B-cell lymphoma
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101388-PIP01-24-M02 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia
  • QUVIVIQ
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100079-PIP01-21-M04 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101572-PIP01-24
  • Nogapendekin alfa
  • Inbakicept
  • Treatment of malignant bladder neoplasms
  • ANKTIVA
  • ANKTIVA
  • Uro-Nephrology
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 29/11/2024
MHRA-100412-PIP01-22-M03 (update)
  • vadadustat
  • Treatment of anaemia due to chronic disorders
  • VAFSEO
  • VAFSEO
  • Haematology-Hemostaseology
  • Other: Anti-anaemic preparations
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100149-PIP01-21-M03 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101465-PIP01-24
  • anitocabtagene autoleucel
  • Treatment of multiple myeloma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 29/11/2024
MHRA-101547-PIP01-24
  • IgG-like T cell engager binding to DLL3 and CD3
  • Treatment of small cell lung carcinoma
  • Treatment of neuroendocrine carcinoma, (excluding neuroblastoma)
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 29/11/2024
MHRA-100524-PIP01-22-M04 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100523-PIP01-22-M04 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101516-PIP01-24-M01 (update)
  • FLUTICASONE FUROATE
  • VILANTEROL TRIFENATATE
  • Treatment of asthma
  • Relvar Ellipta
  • BREO ELLIPTA
  • BREO ELLIPTA
  • Relvar Ellipta
  • RELVARE
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • BREO ELLIPTA
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • BREO ELLIPTA
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100238-PIP01-21-M02 (update)
  • AVELUMAB
  • Treatment of malignant neoplasms of the central nervous system
  • Treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the lymphoid tissue.
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100916-PIP01-23-M02 (update)
  • ELUXADOLINE
  • Treatment of diarrhoea-predominant irritable bowel syndrome
  • Viberzi
  • Viberzi
  • Viberzi
  • Viberzi
  • Truberzi
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101422-PIP02-24
  • single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B and the N terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein.
  • (mRNA-1083)
  • Prevention of influenza and coronavirus disease 2019 (COVID-19)
  • NA
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-101467-PIP01-24
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Other: Neuromuscular disorders
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-100392-PIP01-21-M05 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
  • TOZINAMERAN
  • TOZINAMERAN/FAMTOZINAMERAN
  • TOZINAMERAN/RILTOZINAMERAN
  • RAXTOZINAMERAN
  • 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. Yes 29/11/2024
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