Displaying 461 - 480 of 891
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
MHRA-101249-PIP01-23-M01 (update)
  • Tovorafenib
  • Treatment of paediatric low grade glioma
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
MHRA-101162-PIP01-23-M01 (update)
  • LETERMOVIR
  • Prevention of cytomegalovirus infection
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PRVEYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • tablet
  • PREVYMIS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100646-PIP01-22-M02 (update)
  • TOLVAPTAN
  • Treatment of dilutional hyponatraemia
  • Treatment of polycystic kidney disease
  • Samsca
  • Jinarc
  • Samsca
  • Jinarc
  • Uro-Nephrology
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100372-PIP01-21-M01 (update)
  • concizumab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Alhemo
  • Alhemo
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100143-PIP01-21-M02 (update)
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of chronic viral hepatitis B
  • Vemlidy
  • Vemlidy
  • Vemlidy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100779-PIP01-22-M02 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101262-PIP01-23-M01 (update)
  • DIENOGEST
  • ETHINYLESTRADIOL
  • Prevention of pregnancy
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100695-PIP01-22-M04 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Hemgenix
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100240-PIP01-21-M04 (update)
  • BOSUTINIB
  • Treatment of chronic myeloid leukemia
  • Bosulif
  • Bosulif
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101027-PIP01-23-M01 (update)
  • ANIFROLUMAB
  • Treatment of Systemic Lupus Erythematosus
  • Saphnelo
  • Saphnelo
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100718-PIP01-22-M02 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100203-PIP01-21-M02 (update)
  • Avacopan
  • Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
  • Tavneos
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101234-PIP01-23-M01 (update)
  • ALIROCUMAB
  • Treatment of elevated cholesterol
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101293-PIP01-23-M01 (update)
  • METHOXYFLURANE
  • Treatment of acute pain
  • Penthrox
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101141-PIP01-23-M01 (update)
  • mavacamten
  • Treatment of hypertrophic cardiomyopathy
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • CAMZYOS
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
MHRA-101212-PIP01-23-M01 (update)
  • CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
  • enmetazobactam
  • Treatment of infections caused by gram-negative organisms
  • EXBLIFEP
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No