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Displaying 1 - 20 of 426
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101003-PIP01-23-M01 (update)
  • garadacimab
  • Prevention of hereditary angioedema
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/03/2024
MHRA-100544-PIP01-22-M02 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101131-PIP01-23-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCTYO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100123-PIP01-21-M02 (update)
  • SARILUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Kevzara
  • Kevzara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/01/2024
MHRA-100369-PIP01-21-M02 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold 123 mg capsules
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101073-PIP01-23-M01 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100547-PIP01-22-M02 (update)
  • PEGINTERFERON BETA-1A
  • Treatment of multiple sclerosis.
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-101000-PIP01-23-M01 (update)
  • Rilzabrutinib
  • Treatment of Immune thrombocytopenia
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100440-PIP01-22-M02 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • BICTEGRAVIR
  • Treatment of Human immunodeficiency virus (HIV) infection
  • Biktarvy
  • Biktarvy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100336-PIP01-21-M02 (update)
  • Soticlestat
  • Treatment of Dravet Syndrome
  • Treatment of Lennox-Gastaut Syndrome
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100225-PIP01-21-M02 (update)
  • PARATHYROID HORMONE
  • Treatment of hypoparathyroidism
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
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-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-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