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Displaying 1 - 20 of 797
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100268-PIP01-21-M04 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of acute lymphoblastic leukaemia
  • Besponsa
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101941-PIP01-25
  • Velaprumig
  • Thyroid eye disease
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101855-PIP01-25
  • unasnemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101866-PIP01-25
  • Humanised IgG1 monoclonal antibody against SEZ6 conjugated to a Top1 inhibitor
  • Treatment of small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100479-PIP01-22-M04 (update)
  • POSACONAZOLE
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101461-PIP01-24
  • Zasocitinib
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101489-PIP01-24-M02 (update)
  • Enlicitide (decanoate)
  • Treatment of lipid disorders
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100676-PIP01-22-M02 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Descovy
  • Descovy
  • Descovy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100677-PIP01-22-M02 (update)
  • COBICISTAT
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Tybost
  • Tybost
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101906-PIP01-25
  • florbetaben (18F)
  • Diagnosis of cardiac amyloidosis
  • Neuraceq
  • Neuraceq
  • Neuraceq
  • Neurology
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
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