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Displaying 161 - 173 of 173
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
MHRA-100070-PIP01-21
  • molnupiravir
  • Treatment 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 19/11/2021
MHRA-100022-PIP01-21
  • bimekizumab
  • Hidradenitis suppurativa
  • Immunology -Rheumatology-Transplantation
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/11/2021
MHRA-100038-PIP01-21
  • Recombinant protein derived from the SARS CoV2 prefusion Spike delta TM protein adjuvanted with AS03
  • Prevention of Covid-19
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100028-PIP01-21
  • tixagevimab (AZD8895)
  • cilgavimab (AZD1061)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Treatment 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 03/11/2021
MHRA-100120-PIP01-21
  • TOCILIZUMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • RoActemra
  • RoActemra
  • Infectious diseases
  • Other: Covid-19 pandemic
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100114-PIP01-21
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100066-PIP01-21
  • efgartigimod alfa
  • Treatment of myastenia gravis (MG)
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100021-PIP01-21
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 03/11/2021
MHRA-100149-PIP01-21
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid (proposed invented name)
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 21/10/2021