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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100949-PIP01-23-M01 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne muscular dystrophy
  • Not available
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100482-PIP01-22-M01 (update)
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of Niemann-Pick disease type C
  • Not available at present
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100141-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA PEN
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101117-PIP01-23-M01 (update)
  • ORITAVANCIN
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Tenkasi
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Tenkasi
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101188-PIP01-23-M01 (update)
  • fosdenopterin
  • Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A
  • Nulibry
  • Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101071-PIP01-23-M01 (update)
  • pegzilarginase
  • Treatment of hyperargininaemia
  • Loargys
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100606-PIP01-22-M01 (update)
  • sparsentan
  • Treatment of focal segmental glomerulosclerosis
  • Filspari
  • Filspari
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100253-PIP01-21-M01 (update)
  • Zuranolone
  • Treatment of post-partum depression
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100043-PIP01-21-M01 (update)
  • zilucoplan
  • Treatment of myasthenia gravis
  • Zilbrysq
  • Zilqivik
  • Neurology
  • Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100473-PIP01-22-M01 (update)
  • Recombinant COVID-19 subunit nanoparticle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • SKYCovion
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100992-PIP01-23-M01 (update)
  • danicopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Voydeya
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100982-PIP01-23-M01 (update)
  • pegunigalsidase alfa
  • Treatment of Fabry disease
  • Elfabrio
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100975-PIP01-23-M01 (update)
  • ERENUMAB
  • Prevention of migraine headaches
  • Aimovig
  • Aimovig
  • Aimovig
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100470-PIP01-22-M01 (update)
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
  • Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100235-PIP01-21-M02 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100986-PIP01-23-M01 (update)
  • ENCORAFENIB
  • Treatment of melanoma
  • Braftovi
  • Braftovi
  • Bravtovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100985-PIP01-23-M01 (update)
  • BINIMETINIB
  • Treatment of melanoma
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101149-PIP01-23-M01 (update)
  • elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)
  • Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)
  • Vimizim 1mg/ml concentrate for solution for infusion
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100093-PIP01-21-M03 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100406-PIP01-21-M02 (update)
  • Marstacimab
  • 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
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