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Displaying 161 - 180 of 600
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100426-PIP01-22-M01 (update)
  • ligelizumab
  • Treatment of chronic spontaneous urticaria
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100135-PIP01-21
  • anti-CD40L humanized monoclonal antibody (SAR441344)
  • Treatment of Sjogren's Syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100195-PIP01-21-M01 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/05/2022
MHRA-100195-PIP01-21-M02 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
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-100195-PIP01-21-M04 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluxa
  • 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 30/04/2024
MHRA-100204-PIP01-21
  • verdiperstat
  • Treatment of Amyotrophic lateral sclerosis
  • Dazluma
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100194-PIP01-21
  • sivopixant
  • Treatment of unexplained or refractory chronic cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100309-PIP01-21
  • gantenerumab
  • Prevention of Alzheimer's disease
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100301-PIP01-21
  • Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab )
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/05/2022
MHRA-100709-PIP01-22-M02 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100396-PIP01-21
  • sugemalimab
  • Treatment of non-small cell lung cancer (NSCLC)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100224-PIP01-21
  • Etrasimod L-arginine
  • Treatment of ulcerative colitis
  • Not available at present
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100224-PIP01-21-M01 (update)
  • Etrasimod L-arginine
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100270-PIP01-21-M01 (update)
  • crinecerfont
  • Treatment of congenital adrenal hyperplasia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100316-PIP01-21
  • latozinemab
  • Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100330-PIP01-21 -M01 (update)
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Not available at present
  • Other: Metabolic disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100037-PIP01-21-M01 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/disfunction
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022