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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
PIP Number MHRA-100584-PIP02-23 Active Substance
  • Live attenuated respiratory syncytial virus (RSV)
 Conditions / Indications
  • Prevention of respiratory syncytial virus (RSV) disease
 Invented Name Therapeutic area
  • Vaccines
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101048-PIP01-23 Active Substance
  • doruxapapogenum ralaplasmidum
 Conditions / Indications
  • Treatment of recurrent respiratory papillomatosis
 Invented Name Therapeutic area
  • Infectious diseases
  • Oto-Rhino-Laryngology
  • Vaccines
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100958-PIP01-23 Active Substance
  • bidridistrogene xeboparvovec
 Conditions / Indications
  • Treatment of Limb-girdle muscular dystrophy
 Invented Name Therapeutic area
  • Neurology
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100882-PIP01-23-M01 (update) Active Substance
  • Glucagon analogue linked to a human immunoglobulin Fc fragment
 Conditions / Indications
  • Treatment of congenital hyperinsulinism
 Invented Name Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101106-PIP01-23 Active Substance
  • LY3884963 (PR006A)
 Conditions / Indications
  • Treatment of frontotemporal dementia
 Invented Name Therapeutic area
  • Neurology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101469-PIP01-24 Active Substance
  • Garetosmab
 Conditions / Indications
  • Treatment of fibrodysplasia ossificans progressiva (FOP)
 Invented Name
  • FOPSIVVA
 Therapeutic area
  • Other: Musculoskeletal Disease
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100235-PIP01-21-M03 (update) Active Substance
  • Sotrovimab
 Conditions / Indications
  • Treatment of coronavirus disease 2019 (COVID-19)
 Invented Name
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100222-PIP01-21-M03 (update) Active Substance
  • romosozumab
 Conditions / Indications
  • Treatment of osteoporosis
 Invented Name
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
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  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
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  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100336-PIP01-21-M03 (update) Active Substance
  • soticlestat
 Conditions / Indications
  • Treatment of Dravet Syndrome. Treatment of Lennox-Gastaut Syndrome.
 Invented Name Therapeutic area
  • Neurology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100254-PIP01-21-M02 (update) Active Substance
  • epcoritamab
 Conditions / Indications
  • Treatment of mature B-cell lymphoma
 Invented Name
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101388-PIP01-24-M02 (update) Active Substance
  • DARIDOREXANT HYDROCHLORIDE
 Conditions / Indications
  • Treatment of insomnia
 Invented Name
  • QUVIVIQ
 Therapeutic area
  • Psychiatry
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100079-PIP01-21-M04 (update) Active Substance
  • GILTERITINIB FUMARATE
 Conditions / Indications
  • Treatment of acute myeloid leukaemia (AML)
 Invented Name
  • Xospata
  • Xospata
 Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101572-PIP01-24 Active Substance
  • Nogapendekin alfa
  • Inbakicept
 Conditions / Indications
  • Treatment of malignant bladder neoplasms
 Invented Name
  • ANKTIVA
  • ANKTIVA
 Therapeutic area
  • Uro-Nephrology
  • Oncology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100412-PIP01-22-M03 (update) Active Substance
  • vadadustat
 Conditions / Indications
  • Treatment of anaemia due to chronic disorders
 Invented Name
  • VAFSEO
  • VAFSEO
 Therapeutic area
  • Haematology-Hemostaseology
  • Other: Anti-anaemic preparations
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100149-PIP01-21-M03 (update) Active Substance
  • NVX-CoV2373
 Conditions / Indications
  • Prevention of coronavirus disease 2019 (COVID-19)
 Invented Name
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
 Therapeutic area
  • Vaccines
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101465-PIP01-24 Active Substance
  • anitocabtagene autoleucel
 Conditions / Indications
  • Treatment of multiple myeloma
 Invented Name Therapeutic area
  • Oncology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101547-PIP01-24 Active Substance
  • IgG-like T cell engager binding to DLL3 and CD3
 Conditions / Indications
  • Treatment of small cell lung carcinoma
  • Treatment of neuroendocrine carcinoma, (excluding neuroblastoma)
 Invented Name
  • Not available at present
 Therapeutic area
  • Oncology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100524-PIP01-22-M04 (update) Active Substance
  • gadopiclenol
 Conditions / Indications
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
 Invented Name
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
 Therapeutic area
  • Diagnostic
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100523-PIP01-22-M04 (update) Active Substance
  • gadopiclenol
 Conditions / Indications
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
 Invented Name
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
 Therapeutic area
  • Diagnostic
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101516-PIP01-24-M01 (update) Active Substance
  • FLUTICASONE FUROATE
  • VILANTEROL TRIFENATATE
 Conditions / Indications
  • Treatment of asthma
 Invented Name
  • 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
 Therapeutic area
  • Pneumology - Allergology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
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