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Displaying 521 - 540 of 875
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101265-PIP01-23
  • efgartigimod alfa
  • Treatment of thyroid eye disease
  • Vyvgar
  • Vyvgart
  • Vyvgart
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101226-PIP01-23
  • Volrustomig
  • Treatment of cervical cancer
  • Treatment of renal cell carcinoma
  • Treatment of lung cancer
  • Treatment of mesothelioma
  • Volrustomig
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101222-PIP01-23
  • SJP-0132
  • Treatment of Dry Eye Disease
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101093-PIP02-23
  • satralizumab
  • Treatment for thyroid eye disease (TED)
  • Enspryng
  • Enspryng
  • Enspryng
  • Neurology
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100564-PIP01-22-M03 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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-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-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-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-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-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-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
MHRA-100037-PIP01-21-M02 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/dysfunction
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100485-PIP01-22-M02 (update)
  • AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide
  • Treatment of acute myeloid leukaemia
  • Tapotoclax
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100068-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101008-PIP01-23-M01 (update)
  • AMBRISENTAN
  • Pulmonary Arterial Hypertension
  • Volibris
  • Volibris
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No