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Displaying 81 - 100 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100584-PIP02-23
  • Live attenuated respiratory syncytial virus (RSV)
  • Prevention of respiratory syncytial virus (RSV) disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-101048-PIP01-23
  • doruxapapogenum ralaplasmidum
  • Treatment of recurrent respiratory papillomatosis
  • Infectious diseases
  • Oto-Rhino-Laryngology
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-100958-PIP01-23
  • bidridistrogene xeboparvovec
  • Treatment of Limb-girdle muscular dystrophy
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-100882-PIP01-23-M01 (update)
  • Glucagon analogue linked to a human immunoglobulin Fc fragment
  • Treatment of congenital hyperinsulinism
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101106-PIP01-23
  • LY3884963 (PR006A)
  • Treatment of frontotemporal dementia
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
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