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Displaying 101 - 120 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100068-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100361-PIP01-21-M02 (update)
  • GOLIMUMAB
  • Treatment of ulcerative colitis
  • Simponi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100283-PIP01-21-M02 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100775-PIP01-22-M01 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • maralixibat chloride
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 01/08/2023
MHRA-100775-PIP01-22-M02 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • Livmarli (maralixibat chloride)
  • LIVMARLI
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 01/08/2023
MHRA-100778-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of ulcerative colitis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100786-PIP01-22-M01 (update)
  • TOFACITINIB CITRATE
  • Treatment of ulcerative colitis
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100137-PIP01-21-M02 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100931-PIP01-23-M01 (update)
  • mirikizumab
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100625-PIP01-22-M01 (update)
  • RISANKIZUMAB
  • Treatment of psoriasis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100991-PIP01-23
  • Maralixibat chloride
  • Treatment of progressive familial intrahepatic cholestasis (PFIC)
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/01/2024
MHRA-100916-PIP01-23-M01 (update)
  • ELUXADOLINE
  • Treatment of diarrhoea irritable bowel syndrome.
  • Viberzi
  • Viberzi
  • Viberzi
  • Viberzi
  • Truberzi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100089-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/04/2024
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-100046-PIP01-21-M01 (update)
  • cenobamate
  • Treatment of epilepsy
  • ONTORZY
  • Xcopri
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 03/11/2021
MHRA-100097-PIP01-21-M01 (update)
  • eladocagene exuparvovec
  • Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
  • Upstaza
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100098-PIP01-21-M01 (update)
  • ATALUREN
  • Treatment of dystrophinopathy
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100118-PIP01-21-M01 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100087-PIP01-21-M01 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes
  • VIMPAT
  • lacosamide
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • lacosamide
  • lacosamide
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022