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Displaying 81 - 100 of 773
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100095-PIP01-21-M03 (update)
  • DORAVIRINE
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Pifeltro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100919-PIP01-23
  • Bepirovirsen
  • Treatment of chronic hepatitis B infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100865-PIP01-23-M01 (update)
  • RILPIVIRINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • REKAMBYS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100195-PIP01-21-M03 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100758-PIP01-22-M01 (update)
  • BEZLOTOXUMAB
  • Prevention of recurrence of Clostridioides difficile infection
  • ZINPLAVA
  • ZINPLAVA
  • ZINPLAVA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100907-PIP01-23-M01 (update)
  • CEFTOLOZANE
  • TAZOBACTAM
  • Treatment of pneumonia
  • ZERBAXA
  • ZERBAXA
  • ZERBAXA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100579-PIP01-22-M03 (update)
  • Maribavir
  • Treatment of cytomegalovirus (CMV) infection
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtencity
  • Livtenicty
  • Livtencity
  • Livtencity
  • Livtencity
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100901-PIP01-23-M01 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100303-PIP01-21-M02 (update)
  • DARUNAVIR
  • COBICISTAT
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M01 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M02 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100901-PIP01-23-M02 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria / Cabenuva
  • Vocabria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100235-PIP01-21-M02 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101117-PIP01-23-M01 (update)
  • ORITAVANCIN
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Tenkasi
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Tenkasi
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100440-PIP01-22-M02 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • BICTEGRAVIR
  • Treatment of Human immunodeficiency virus (HIV) infection
  • Biktarvy
  • Biktarvy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100971-PIP01-23
  • Sipavibart (AZD3152)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100913-PIP01-23
  • mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100300-PIP01-21-M03 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024