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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
PIP Number MHRA-100950-PIP01-23 Active Substance
  • lutetium-177 (177Lu) rhPSMA 10.1
 Conditions / Indications
  • Treatment of prostate cancer
 Invented Name Therapeutic area
  • Oncology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100872-PIP01-23 Active Substance
  • pudexacianinium chloride
 Conditions / Indications
  • Visualisation of ureter
 Invented Name Therapeutic area
  • Uro-Nephrology
  • Gastroenterology-Hepatology
  • Diagnostic
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Oncology
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100866-PIP01-23 Active Substance
  • obecabtagene autoleucel
 Conditions / Indications
  • Treatment of acute lymphoblastic leukaemia (ALL)
 Invented Name Therapeutic area
  • Oncology
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100593-PIP01-22 Active Substance
  • aticaprant
 Conditions / Indications
  • Treatment of Major Depressive Disorder
 Invented Name
  • Not available at present
 Therapeutic area
  • Psychiatry
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101016-PIP01-23 Active Substance
  • ublituximab
 Conditions / Indications
  • Treatment of multiple sclerosis
Invented Name
  • Briumvi
  • Briumvi
 Therapeutic area
  • Neurology
 Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101024-PIP01-23-M01 (update) Active Substance
  • gadoquatrane
 Conditions / Indications
  • Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging
 Invented Name Therapeutic area
  • Diagnostic
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100932-PIP01-23-M01 (update) Active Substance
  • Peanut Flour
Conditions / Indications
  • Treatment of peanut allergy
 Invented Name
  • Palforzia
  • PALFORZIA
  • Palforzia
 Therapeutic area
  • Pneumology - Allergology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100188-PIP01-21-M02 (update) Active Substance
  • lebrikizumab
 Conditions / Indications
  • treatment of atopic dermatitis
Invented Name Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101028-PIP01-23-M01 (update) Active Substance
  • Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)
 Conditions / Indications
  • Prevention of cholera
 Invented Name
  • Vaxchora
 Therapeutic area
  • Vaccines
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101004-PIP01-23-M01 (update) Active Substance
  • APIXABAN
 Conditions / Indications
  • Treatment of venous thromboembolism
 Invented Name
  • Eliquis
  • Eliquis
  • Eliquis
  • Eliquis
 Therapeutic area
  • Cardiovascular Diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100949-PIP01-23-M01 (update) Active Substance
  • Delandistrogene moxeparvovec
 Conditions / Indications
  • Treatment of Duchenne muscular dystrophy
 Invented Name
  • Not available
 Therapeutic area
  • Neurology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100482-PIP01-22-M01 (update) Active Substance
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
 Conditions / Indications
  • Treatment of Niemann-Pick disease type C
 Invented Name
  • Not available at present
 Therapeutic area
  • Neurology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100141-PIP01-21-M01 (update) Active Substance
  • BENRALIZUMAB
 Conditions / Indications
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
 Invented Name
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA PEN
 Therapeutic area
  • Pneumology - Allergology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101188-PIP01-23-M01 (update) Active Substance
  • fosdenopterin
 Conditions / Indications
  • Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A
 Invented Name
  • Nulibry
 Therapeutic area
  • Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-101071-PIP01-23-M01 (update) Active Substance
  • pegzilarginase
 Conditions / Indications
  • Treatment of hyperargininaemia
 Invented Name
  • Loargys
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100606-PIP01-22-M01 (update) Active Substance
  • sparsentan
Conditions / Indications
  • Treatment of focal segmental glomerulosclerosis
 Invented Name
  • Filspari
  • Filspari
 Therapeutic area
  • Uro-Nephrology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100253-PIP01-21-M01 (update) Active Substance
  • Zuranolone
 Conditions / Indications
  • Treatment of post-partum depression
 Invented Name Therapeutic area
  • Psychiatry
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100043-PIP01-21-M01 (update) Active Substance
  • zilucoplan
 Conditions / Indications
  • Treatment of myasthenia gravis
 Invented Name
  • Zilbrysq
  • Zilqivik
 Therapeutic area
  • Neurology
  • Other: Complement inhibitor for treatment of the autoimmune disease myasthenia gravis
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100473-PIP01-22-M01 (update) Active Substance
  • Recombinant COVID-19 subunit nanoparticle
 Conditions / Indications
  • Prevention of coronavirus disease 2019 (COVID-19)
 Invented Name
  • SKYCovion
 Therapeutic area
  • Vaccines
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100982-PIP01-23-M01 (update) Active Substance
  • pegunigalsidase alfa
 Conditions / Indications
  • Treatment of Fabry disease
 Invented Name
  • Elfabrio
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
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