Displaying 41 - 60 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100078-PIP01-21-M02 (update)
  • AVIBACTAM
  • AZTREONAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100479-PIP01-22-M01 (update)
  • POSACONAZOLE
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100028-PIP01-21-M01 (update)
  • TIXAGEVIMAB
  • CILGAVIMAB
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Treatment of COVID-19
  • Evusheld
  • Evusheld
  • Evusheld
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100564-PIP01-22-M01 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100601-PIP01-22-M01 (update)
  • elasomeran
  • imelasomeran
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax bivalent Original / Omicron
  • Spikevax
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
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 -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-100579-PIP01-22-M01 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M02 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100604-PIP01-22-M01 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 02/02/2023
MHRA-100648-PIP01-22-M01 (update)
  • TECOVIRIMAT MONOHYDRATE
  • Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)
  • Tecovirimat SIGA
  • Tecovirimat SIGA
  • TPOXX
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100440-PIP01-22-M01 (update)
  • BICTEGRAVIR
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of Human immunodeficiency virus (HIV-1) infection
  • Biktarvy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100585-PIP01-22
  • Adintrevimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Bredaygio
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100637-PIP01-22
  • Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus
  • Treatment of chronic hepatitis D infection
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
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-100552-PIP01-22-M01 (update)
  • RILPIVIRINE HYDROCHLORIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • edurant
  • edurant
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/05/2023
MHRA-100078-PIP01-21-M03 (update)
  • AZTREONAM
  • AVIBACTAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100571-PIP01-22-M01 (update)
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Treatment of chronic viral hepatitis B
  • Viread
  • Viread
  • Viread
  • Viread
  • Viread
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100543-PIP01-22-M01 (update)
  • LAMIVUDINE
  • DOLUTEGRAVIR
  • Treatment of Human Immunodeficiency virus type 1 (HIV - 1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100669-PIP01-22-M01 (update)
  • EMTRICITABINE
  • RILPIVIRINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of Human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023