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Displaying 381 - 400 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-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-100065-PIP01-21-M01 (update)
  • TICAGRELOR
  • Prevention of thromboembolic events
  • Brilique
  • Brilique
  • Brilique
  • Brilique
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 03/11/2021
MHRA-100183-PIP01-21-M01 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100250-PIP01-21-M01 (update)
  • VERICIGUAT
  • Treatment of left ventricular failure
  • Verquvo
  • Verquvo
  • Verquvo
  • Verquvo
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100308-PIP01-21-M01 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100343-PIP01-21-M01 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • systemic sclerosis
  • idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100329-PIP01-21-M01 (update)
  • EDOXABAN TOSYLATE
  • Treatment of venous thromboembolism
  • Prevention of arterial thromboembolism
  • Prevention of Venous thromboembolism
  • Lixiana film-coated tablets
  • Lixiana
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100855-PIP01-23-M01 (update)
  • DOPAMINE HYDROCHLORIDE
  • Treatment of vascular hypotensive disorders
  • Neoatricon
  • Cardiovascular Diseases
  • Neonatology - Paediatric Intensive Care
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 25/05/2023
MHRA-100884-PIP01-23-M01 (update)
  • SACUBITRIL
  • VALSARTAN
  • Treatment of Heart failure
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Entresto
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Neparvis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 25/05/2023
MHRA-100250-PIP01-21-M02 (update)
  • VERICIGUAT
  • Treatment of left ventricular failure
  • Verquvo
  • Verquvo
  • Verquvo
  • Verquvo
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100846-PIP01-23-M01 (update)
  • ENALAPRIL MALEATE
  • Treatment of heart failure
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/06/2023