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Displaying 661 - 669 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Sort descending Compliance outcome Date Published
MHRA-100646-PIP01-22-M02 (update)
  • TOLVAPTAN
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
  • Samsca
  • Jinarc
  • Samsca
  • Jinarc
  • Uro-Nephrology
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100811-PIP01-22-M02 (update)
  • Vamorolone
  • Treatment of Duchenne muscular dystrophy
  • AGAMREE
  • Neurology
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-100197-PIP01-21-M02 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-101249-PIP01-23-M01 (update)
  • Tovorafenib
  • Treatment of paediatric low grade glioma
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-101304-PIP01-23-M01 (update)
  • FILGOTINIB MALEATE
  • Treatment of ulcerative colitis
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100564-PIP01-22-M03 (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 01/05/2024
MHRA-100601-PIP01-22-M03 (update)
  • elasomeran
  • imelasomeran
  • DAVESOMERAN
  • ANDUSOMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB1.5
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024