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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100349-PIP01-21-M03 (update)
  • Rezafungin acetate
  • Treatment of invasive candidiasis
  • Rezzayo
  • Rezzayo
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101916-PIP01-25
  • PF-07248144
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101909-PIP01-25
  • 5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one
  • Treatment of prostate malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100462-PIP01-22-M03 (update)
  • FENFLURAMINE HYDROCHLORIDE
  • Treatment of Dravet syndrome.
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Fintepla
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101159-PIP02-25
  • Sacituzumab Tirumotecan
  • Treatment of urothelial carcinoma
  • sac-TMT (佳泰莱®)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101984-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of elevated cholesterol
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101781-PIP01-25
  • pozelimab
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Veopoz
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101782-PIP01-25
  • cemdisiran sodium
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101471-PIP01-24
  • Respiratory syncytial virus, prefusion F protein, virus-like particle; Human metapneumovirus, prefusion F protein, virus-like particle
  • IVX-A12
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Prevention of lower respiratory tract disease caused by human metapneumovirus
  • Not available
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100099-PIP01-21-M05 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100289-PIP01-21-M04 (update)
  • GALCANEZUMAB
  • Prevention of migraine headaches.
  • Emgality
  • Emgality 120 mg solution for injection in pre-filled syringe
  • Neurology
  • Pain
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102010-PIP01-25
  • PEGCETACOPLAN
  • Treatment of geographic atrophy secondary to age related macular degeneration.
  • Syfovre
  • Syfovre
  • Syfovre
  • Syfovre
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101021-PIP01-23-M03 (update)
  • FILGOTINIB MALEATE
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100722-PIP01-22-M01 (update)
  • Ritlecitinib
  • Treatment of vitiligo
  • Litfulo
  • Litfulo
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101786-PIP02-25
  • (R)-N-(3-(2-Chloro-5-fluorophenyl)-6-(5-cyano-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-1-oxoisoindolin-4-yl)-3-fluoro-5-(trifluoromethyl)benzamide
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101388-PIP01-24-M03 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia
  • QUVIVIQ
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100291-PIP01-21-M02 (update)
  • imetelstat
  • Treatment of acute myeloid leukaemia (AML)
  • Treatment of myelodysplastic syndromes (MDS), including juvenile myelomonocytic leukaemia (JMML)
  • RYTELO
  • RYTELO
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100123-PIP01-21-M03 (update)
  • SARILUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Kevzara
  • Kevzara
  • Kevzara
  • Kevzara
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100342-PIP01-21-M02 (update)
  • arimoclomol citrate
  • Treatment of Niemann-Pick disease type C
  • MIPLYFFA
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101812-PIP01-25
  • BICTEGRAVIR
  • LENACAPAVIR SODIUM
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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