Displaying 601 - 620 of 773
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
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-100056-PIP01-21
  • BENRALIZUMAB
  • Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE)
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100057-PIP01-21
  • BENRALIZUMAB
  • Treatment of eosinophilic oesophagitis
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100068-PIP01-21
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio; Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 17/03/2022
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-100208-PIP01-21
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of non-alcoholic steatohepatitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100275-PIP01-21
  • SEMAGLUTIDE
  • Treatment of non-alcoholic steatohepatitis (NASH)
  • Ozempic
  • OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
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-100165-PIP01-21
  • PF-06865571
  • Treatment of non-alcoholic steatohepatitis
  • PF-06865571
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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-100190-PIP01-21
  • Ordesekimab
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). 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-100209-PIP01-21
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of obesity
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100514-PIP01-22
  • Gliadin Protease
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100224-PIP02-22
  • Etrasimod L-arginine
  • Treatment of Crohn’s disease
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023