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Displaying 21 - 40 of 1186
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100544-PIP01-22-M03 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100743-PIP01-22-M03 (update)
  • efgartigimod alfa
  • Treatment of generalised myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100066-PIP01-21-M02 (update)
  • efgartigimod alfa
  • Treatment of myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101604-PIP01-24
  • efgartigimod alfa
  • Treatment of Sjögren's disease
  • Vyvgart
  • Vyvgart
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101771-PIP01-24
  • SEMAGLUTIDE
  • Prevention of cardiovascular events in patients with atherosclerosis
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Rybelsus
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101720-PIP01-24-M01 (update)
  • PEGCETACOPLAN
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • ASPAVELI
  • ASPAVELI
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101718-PIP01-24
  • Human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant
  • Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101704-PIP01-24
  • Nucresiran sodium
  • Treatment of transthyretin amyloidosis
  • Neurology
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101676-PIP01-24
  • HUMAN ANTI-D IMMUNOGLOBULIN
  • Prevention of Rhesus (Rh) isoimmunisation
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Haematology-Hemostaseology
  • Other: Immunology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101674-PIP01-24
  • Linvoseltamab
  • Treatment of multiple myeloma
  • LYNOZYFIC
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101550-PIP01-24
  • Troriluzole Hydrochloride
  • Treatment of hereditary spinocerebellar ataxia
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100909-PIP01-23-M02 (update)
  • ABEMACICLIB
  • Treatment of Ewing's sarcoma
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101006-PIP01-23-M02 (update)
  • IMLIFIDASE
  • Prevention of graft rejection following solid organ transplantation
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100118-PIP01-21-M03 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101678-PIP01-24
  • Mirdametinib
  • Treatment of neurofibromatosis type 1
  • Not available at present
  • Gomeklio
  • Gomeklio
  • Neurology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100475-PIP01-22-M02 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101044-PIP01-23-M02 (update)
  • INCLISIRAN SODIUM
  • Treatment of elevated cholesterol
  • Leqvio
  • Leqvio
  • Endocrinology-Gynaecology-Fertility-metabolism
  • Other: chemically synthesized small interfering RNA (siRNA)
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101707-PIP01-24
  • AMG 193
  • Treatment of non-small cell lung cancer
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101729-PIP01-24
  • Ifinatamab deruxtecan
  • Treatment of prostate malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101730-PIP01-24
  • Ifinatamab deruxtecan
  • Treatment of oesophageal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No