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Displaying 41 - 60 of 828
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101376-PIP01-24
  • Frexalimab
  • Treatment of Type 1 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101921-PIP01-25
  • quemliclustat
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100545-PIP01-22-M01 (update)
  • Lutetium (177Lu) edotreotide
  • Treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101876-PIP01-25
  • rinatabart sesutecan
  • Treatment of endometrial cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101246-PIP01-23-M02 (update)
  • MEROPENEM
  • VABORBACTAM
  • Treatment of Gram-negative bacterial infections
  • Vaborem
  • Vabomere
  • Vaborem
  • Vabomere
  • Vaborem
  • Vabomere
  • Vabomere
  • Vaborem
  • Vaborem
  • Vaborem
  • Vaborem
  • Vaborem
  • Vabomere
  • Vaborem
  • Vaborem
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101955-PIP01-25
  • ARX517
  • Treatment of prostate cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101552-PIP01-24
  • litifilimab
  • Treatment of lupus erythematosus
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101858-PIP01-25
  • atogepant
  • Treatment of migraine headaches
  • Aquipta
  • Aquipta
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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