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Displaying 121 - 140 of 669
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100168-PIP01-21-M01 (update)
  • Naloxegol (as naloxegol oxalate)
  • Treatment of opioid-induced constipation
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
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-100392-PIP01-21-M01 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersio n for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/04/2022
MHRA-100391-PIP01-21-M01 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 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 27/04/2022
MHRA-100392-PIP01-21-M02 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 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 25/05/2023
MHRA-100392-PIP01-21-M03 (update)
  • TOZINAMERAN
  • TOZINAMERAN/ FAMTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 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 30/06/2023
MHRA-100390-PIP01-21-M01 (update)
  • Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/04/2022
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-100279-PIP01-21
  • Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide
  • Diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 04/05/2022
MHRA-100276-PIP01-21-M01 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • brodalumab
  • Lumicef
  • Siliq
  • Kyntheum
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022
MHRA-100276-PIP01-21-M02 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • Kyntheum
  • Lumicef
  • Siliq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100276-PIP01-21-M03 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • Kyntheum
  • Kyntheum
  • Lumicef
  • Siliq
  • Kyntheum
  • Kyntheum
  • Kyntheum
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100052-PIP01-21-M01 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022
MHRA-100052-PIP01-21-M02 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100053-PIP01-21-M01 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022
MHRA-100053-PIP01-21 -M02 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
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-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-100150-PIP01-21
  • AZITHROMYCIN
  • Prevention of bronchopulmonary dysplasia (BPD)
  • Pneumology - Allergology
  • Neonatology - Paediatric Intensive Care
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100106-PIP01-21
  • 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde
  • sodium chloride solution 4.2% (w/v)
  • Treatment of primary ciliary dyskinesia
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022