Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 241 - 260 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100465-PIP01-22-M02 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 19/12/2023
MHRA-100050-PIP01-21-M01 (update)
  • efgartigimod alfa
  • Treatment of immune thrombocytopenia.
  • Vyvgart
  • Vyvgart
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100079-PIP01-21-M02 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukemia
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100921-PIP01-23-M01 (update)
  • AVATROMBOPAG
  • Treatment of Idiopathic Thrombocytopenia Purpura
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
  • Doptelet
  • Avatrombopag
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100406-PIP01-21-M02 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100992-PIP01-23-M01 (update)
  • danicopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Voydeya
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100544-PIP01-22-M02 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100695-PIP01-22-M04 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100372-PIP01-21-M01 (update)
  • concizumab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Alhemo
  • Alhemo
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100614-PIP01-22-M02 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100079-PIP01-21-M03 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100523-PIP01-22-M01 (update)
  • gadopiclenol
  • Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity
  • Not available at present
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100524-PIP01-22-M01 (update)
  • gadopiclenol
  • Diagnostic detection & visualisation of areas with BBB disruption and/or abnormal vascularity
  • Not available at present
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100523-PIP01-22-M02 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100524-PIP01-22-M02 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101024-PIP01-23-M01 (update)
  • gadoquatrane
  • Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100064-PIP01-21-M01 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 03/11/2021
MHRA-100072-PIP01-21-M01 (update)
  • COVID-19 Vaccine (ChAdOx1-S [recombinant])
  • Prevention of coronavirus disease 2019 (COVID-19)
  • COVID-19 Vaccine AstraZeneca
  • COVID-19 Vaccine AstraZeneca
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
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-100021-PIP01-21 -M01 (update)
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022