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Displaying 381 - 400 of 783
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100604-PIP01-22-M02 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101250-PIP01-23-M01 (update)
  • RISANKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101233-PIP01-23-M01 (update)
  • inebilizumab
  • Treatment of neuromyelitis optica spectrum disorders
  • Uplizna
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101093-PIP01-23-M01 (update)
  • satralizumab
  • Treatment of neuromyelitis optica.
  • Enspryng
  • Enspryng
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100283-PIP01-21-M03 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100445-PIP01-22-M01 (update)
  • RAVULIZUMAB
  • Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100120-PIP01-21-M01 (update)
  • TOCILIZUMAB
  • Treatment of Coronavirus disease 2019 (COVID 19)
  • RoActemra
  • RoActemra
  • Infectious diseases
  • Other: COVID 19 Pandemic
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100818-PIP01-22-M02 (update)
  • BEMPEDOIC ACID
  • Treatment of elevated cholesterol
  • Nilemdo® (bempedoic acid) tablets
  • Nilemdo®
  • Nilemdo®
  • Nexletol®
  • Nilemdo®
  • Nilemdo®
  • Nilemdo®
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101238-PIP01-23-M01 (update)
  • UPADACITINIB
  • Treatment of ulcerative colitis
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101198-PIP01-23-M01 (update)
  • RISANKIZUMAB
  • Treatment of Crohn's disease
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100377-PIP01-21-M02 (update)
  • ACALABRUTINIB
  • Treatment of mature B cell neoplasms
  • calquence
  • calquence
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100167-PIP01-21-M02 (update)
  • SODIUM ZIRCONIUM CYCLOSILICATE
  • Treatment of hyperkalaemia
  • Lokelma
  • Lokelma
  • Lokelma
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100719-PIP01-22-M01 (update)
  • LUTETIUM (177LU) OXODOTREOTIDE
  • Treatment of gastroenteropancreatic neuroendocrine tumours
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100258-PIP01-21-M02 (update)
  • Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101264-PIP01-23
  • cemdisiran
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101263-PIP01-23
  • pozelimab
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100363-PIP01-21
  • Repagermanium
  • Treatment of focal segmental glomerulosclerosis (FSGS)
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100191-PIP02-22
  • albaconazole
  • Treatment of vulvovaginal candidiasis
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101210-PIP01-23
  • Zapomeran
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Kostaive
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100918-PIP01-23
  • BELIMUMAB
  • Treatment of systemic sclerosis
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No