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Displaying 361 - 380 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-100099-PIP01-21-M04 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact (in Italy: Nubriveo)
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100105-PIP01-21-M01 (update)
  • ALPRAZOLAM
  • Treatment of epileptic seizures
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100807-PIP01-22-M02 (update)
  • RIMEGEPANT SULFATE
  • Treatment of migraine headaches
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Vydura
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Nurtec ODT
  • Neurology
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-100039-PIP01-21-M01 (update)
  • Cotadutide
  • Treatment of non-alcoholic steatohepatitis (NASH)
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/12/2021
MHRA-100089-PIP01-21-M01 (update)
  • dupilumab
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100168-PIP01-21-M01 (update)
  • Naloxegol (as naloxegol oxalate)
  • Treatment of opioid-induced constipation
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100137-PIP01-21-M01 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
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-100283-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100286-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of ulcerative colitis
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100325-PIP01-21-M01 (update)
  • NALDEMEDINE
  • Treatment of opioid-induced constipation
  • Rizmoic
  • Rizmoic
  • SYMPROIC
  • SYMPROIC
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100211-PIP01-21-M01 (update)
  • VOLANESORSEN SODIUM
  • Treatment of familial chylomicronemia syndrome
  • WAYLIVRA
  • WAYLIVRA
  • Gastroenterology-Hepatology
  • Cardiovascular Diseases
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100376-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Crohn's disease
  • Treatment of Ulcerative colitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 22/12/2022
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-100657-PIP01-22-M01 (update)
  • BULEVIRTIDE
  • Treatment of chronic hepatitis D infection
  • Hepcludex
  • Hepcludex
  • Myrcludex B
  • Gastroenterology-Hepatology
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
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