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Displaying 381 - 400 of 961
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending
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 Sort ascending