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Displaying 141 - 160 of 173
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100196-PIP01-21
  • SARS-CoV-2 virus, beta-propiolactone inactivated
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100339-PIP01-21
  • Autologous selected renal cells
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 04/05/2022
MHRA-100164-PIP01-21
  • (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 18/03/2022
MHRA-100118-PIP02-22
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100218-PIP01-21
  • DUPILUMAB
  • Treatment of chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100054-PIP01-21
  • RO7496998 (AT-527)
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
  • Other: Pandemic
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 18/03/2022
MHRA-100060-PIP01-21
  • 2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100068-PIP01-21
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio; Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 17/03/2022
MHRA-100056-PIP01-21
  • BENRALIZUMAB
  • Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE)
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100057-PIP01-21
  • BENRALIZUMAB
  • Treatment of eosinophilic oesophagitis
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100140-PIP01-21
  • BENRALIZUMAB
  • Treatment of Hypereosinophilic syndrome (HES)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100141-PIP01-21
  • BENRALIZUMAB
  • Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100048-PIP01-21
  • Afamitresgene autoleucel
  • Treatment of soft tissue sarcoma
  • Not available at present.
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100043-PIP01-21
  • zilucoplan
  • Treatment of myasthenia gravis
  • Zilbrysq
  • Zilqivik
  • Neurology
  • Other: Neurodegenerative disorder, auto-immune disease/dysfunction
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100044-PIP01-21
  • seltorexant
  • Treatment of major depressive disorder (MDD)
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100109-PIP01-21
  • Islatravir
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100111-PIP01-21
  • DORAVIRINE
  • Islatravir
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection.
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/12/2021
MHRA-100029-PIP01-21
  • COVID-19 vaccine (Ad26.COV2-S (recombinant))
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2021
MHRA-100052-PIP01-21
  • REGN10933
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not Yet Available
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/11/2021
MHRA-100053-PIP01-21
  • REGN10987
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not Yet Available
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/11/2021