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Displaying 301 - 320 of 1015
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100951-PIP01-23-M03 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of Human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101283-PIP01-23-M01 (update)
  • Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B.
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100364-PIP01-21-M01 (update)
  • Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Arexvy
  • Arexvy
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100116-PIP01-21-M03 (update)
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
  • Treatment of Cystic Fibrosis
  • Kaftrio
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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-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