Displaying 21 - 40 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100117-PIP01-21-M03 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/01/2024
MHRA-100950-PIP01-23
  • lutetium-177 (177Lu) rhPSMA 10.1
  • Treatment of prostate cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100872-PIP01-23
  • pudexacianinium chloride
  • Visualisation of ureter
  • Uro-Nephrology
  • Gastroenterology-Hepatology
  • Diagnostic
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/01/2024
MHRA-101058-PIP01-23
  • SIROLIMUS
  • Treatment of Tuberous Sclerosis
  • Pascomer
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 30/01/2024
MHRA-100866-PIP01-23
  • obecabtagene autoleucel
  • Treatment of acute lymphoblastic leukaemia (ALL)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/01/2024
MHRA-100991-PIP01-23
  • Maralixibat chloride
  • Treatment of progressive familial intrahepatic cholestasis (PFIC)
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/01/2024
MHRA-100593-PIP01-22
  • aticaprant
  • Treatment of Major Depressive Disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/01/2024
MHRA-101016-PIP01-23
  • ublituximab
  • Treatment of multiple sclerosis
  • Briumvi
  • Briumvi
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 20/12/2023
MHRA-101024-PIP01-23-M01 (update)
  • gadoquatrane
  • Diagnosis by evaluation of any known or suspected clinical condition with contrast enhanced magnetic resonance imaging
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100162-PIP01-21-M02 (update)
  • SELEXIPAG
  • Treatment of pulmonary arterial hypertension (PAH)
  • Uptravi
  • Uptravi
  • Uptravi
  • Other: Pulmonary heart disease and diseases of pulmonary circulation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100932-PIP01-23-M02 (update)
  • Defatted powder of peanuts
  • Treatment of peanut allergy
  • Palforzia
  • Palforzia
  • Palforzia
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 19/12/2023
MHRA-100932-PIP01-23-M01 (update)
  • Peanut Flour
  • Treatment of peanut allergy
  • Palforzia
  • PALFORZIA
  • Palforzia
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100188-PIP01-21-M02 (update)
  • lebrikizumab
  • treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101028-PIP01-23-M01 (update)
  • Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)
  • Prevention of cholera
  • Vaxchora
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100642-PIP01-22-M02 (update)
  • Tremelimumab
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).
  • IMJUDO
  • Tremelimumab AstraZeneca
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 19/12/2023
MHRA-101004-PIP01-23-M01 (update)
  • APIXABAN
  • Treatment of venous thromboembolism
  • Eliquis
  • Eliquis
  • Eliquis
  • Eliquis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023
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 19/12/2023