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Displaying 21 - 40 of 876
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101785-PIP01-25-M01 (update)
  • Repinatrabit
  • Treatment of hyperphenylalaninemia
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101174-PIP01-23-M01 (update)
  • LENACAPAVIR SODIUM
  • Lenacapavir
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Sunlenca
  • Yeytuo
  • Sunlenca
  • Yeytuo
  • Sunlenca
  • Yeytuo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102482-PIP01-26
  • Human rabies immune globulin
  • Prevention of rabies infection
  • KAMRAB
  • KAMRAB
  • KAMRAB
  • PlasmaRAB
  • KAMRAB
  • KAMRAB
  • REBINOLIN
  • KAMRAB
  • REBINOLIN
  • KEDRAB
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101583-PIP01-24-M02 (update)
  • Recombinant Varicella Zoster Virus Glycoprotein E
  • Prevention of varicella zoster virus (VZV) reactivation
  • Shingrix
  • Shingrix
  • Shingrix
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102213-PIP01-25
  • Ianalumab
  • Treatment of systemic lupus erythematosus
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100278-PIP01-21
  • Venglustat
  • Treatment of Fabry disease
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102256-PIP01-25
  • Divesiran
  • Treatment of polycythaemia vera
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101943-PIP01-25
  • Adimanebart
  • Treatment of spinal muscular atrophy
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102231-PIP01-25
  • 13 Grass Aqueous Extract
  • Treatment of allergic rhinitis / rhino-conjunctivitis
  • Grassmuno
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100312-PIP01-21-M03 (update)
  • RITLECITINIB TOSYLATE
  • Treatment of alopecia areata
  • Litfulo
  • Litfulo
  • Litfulo
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101902-PIP01-25
  • Bleximenib
  • Treatment of acute myeloid leukaemia
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101727-PIP01-24-M01 (update)
  • RAVULIZUMAB
  • Treatment of primary immunoglobulin A nephropathy
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100614-PIP01-22-M04 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102362-PIP01-26
  • Telisotuzumab adizutecan
  • Treatment of all conditions included in the category of malignant neoplasms.
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101362-PIP01-24-M02 (update)
  • ZANAMIVIR
  • Treatment of Influenza
  • Prevention of Influenza
  • Dectova
  • Dectova
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102117-PIP01-25
  • Efimosfermin alfa
  • Treatment of metabolic dysfunction-associated steatohepatitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100468-PIP01-22-M04 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • VYEPTI 100 mg concentrate for solution for infusion
  • VYEPTI 300 mg concentrate for solution for infusion
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102116-PIP01-25
  • Delpacibart etedesiran
  • Treatment of myotonic disorders
  • Not available at present
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100348-PIP01-21-M02 (update)
  • botaretigene sparoparvovec
  • Treatment of retinitis pigmentosa
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102502-PIP01-26
  • Cemacabtagene ansegedleucel (cema-cel)
  • Treatment of non-Hodgkin B-cell lymphomas.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No