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Displaying 81 - 100 of 843
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100075-PIP02-24
  • leniolisib phosphate
  • Treatment of common variable immunodeficiency
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101953-PIP01-25-M01 (update)
  • Nipocalimab
  • Treatment of myasthenia gravis
  • Not available at present
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102015-PIP01-25
  • Alvelestat tosylate
  • Treatment of alpha-1 antitrypsin deficiency.
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101948-PIP01-25
  • JNJ-79635322 - BCMAxGPRC5DxCD3
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101833-PIP01-25
  • Androgen Receptor (AR) Ligand-Directed Degrader
  • Treatment of prostate malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101818-PIP01-25
  • DUPILUMAB
  • Lichen Simplex Chronicus
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101430-PIP01-24-M01 (update)
  • RAVULIZUMAB
  • Treatment in haematopoietic stem cell transplantation
  • Ultomiris
  • Uro-Nephrology
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100720-PIP01-22-M03 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infections
  • Blujepa
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101903-PIP01-25
  • Ifinatamab deruxtecan
  • Treatment of endometrial cancer
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100605-PIP01-22-M01 (update)
  • SPARSENTAN
  • Treatment of immunoglobulin A nephropathy
  • Filspari
  • Filspari
  • Filspari
  • Filspari
  • Other: Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101945-PIP01-25
  • Hafnium Oxide
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101939-PIP01-25
  • Hafnium Oxide
  • Treatment of head and neck epithelial malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101917-PIP01-25
  • BOTULINUM TOXIN TYPE A
  • Treatment of skin wrinkling.
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101283-PIP01-23-M03 (update)
  • Fitusiran
  • Treatment of haemophilia A
  • Treatment of Haemophilia B
  • Fitusiran
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100797-PIP02-24
  • mRNA encoding Influenza A, H1N1 strain, hemagglutinin glycoprotein, mRNA encoding Influenza A, H3N2 strain, hemagglutinin glycoprotein, mRNA encoding Influenza B/Victoria, hemagglutinin glycoprotein
  • Prevention of influenza disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101985-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101808-PIP01-25-M01 (update)
  • DARVADSTROCEL
  • Treatment of perianal fistula
  • Alofisel
  • Gastroenterology-Hepatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101467-PIP01-24-M01 (update)
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Isembyld
  • Other: Neuromuscular disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100369-PIP01-21-M03 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101592-PIP01-24
  • Afimkibart
  • Treatment of Crohn's disease
  • Human IgG1 kappa monoclonal antibody against tumor necrosis factor-like ligand 1A
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No