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Displaying 281 - 300 of 991
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101097-PIP01-23-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, mpox and related orthopoxvirus infection and disease
  • Imvanex
  • Imvanex
  • Imvamune
  • Jynneos
  • Imvanex
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101097-PIP01-23-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, mpox and related orthopoxvirus infection and disease
  • Imvanex
  • Imvanex
  • Imvamune
  • Jynneos
  • Imvanex
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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-100209-PIP01-21-M01 (update)
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of obesity
  • Not available at present
  • 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-100214-PIP01-21-M04 (update)
  • RAVULIZUMAB
  • Treatment of atypical haemolytic uremic syndrome.
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomriris
  • Ultomriris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100213-PIP01-21-M04 (update)
  • RAVULIZUMAB
  • Treatment of Paroxysmal Nocturnal Haemoglobinuria
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Haematology-Hemostaseology
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-100348-PIP01-21-M01 (update)
  • botaretigene sparoparvovec
  • Treatment of retinitis pigmentosa
PM: decision on the application for modification of an agreed paediatric investigation plan. 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-100167-PIP01-21-M02 (update)
  • SODIUM ZIRCONIUM CYCLOSILICATE
  • Treatment of hyperkalaemia
  • Lokelma
  • Lokelma
  • Lokelma
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) 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