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Displaying 61 - 80 of 1235
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100311-PIP02-24
  • Cetrelimab
  • Treatment of malignant bladder neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100455-PIP01-22-M02 (update)
  • IXAZOMIB
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101661-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of atopic dermatitis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101579-PIP01-24
  • AZD0780
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
  • AZD0780
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100949-PIP01-23-M02 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne muscular dystrophy
  • Elevidys
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101731-PIP01-24
  • Pridopidine hydrochloride
  • Treatment of Huntington disease (HD)
  • Nurzigma
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100517-PIP01-22-M04 (update)
  • APREMILAST
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Otezla 10 mg, 20 mg, 30 mg film coated tablets, Otezla 30 mg film coated tablets
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100443-PIP01-22-M03 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis).
  • Baricitinib Lilly
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100119-PIP01-21-M02 (update)
  • TEZACAFTOR
  • IVACAFTOR
  • Treatment of Cystic Fibrosis
  • Symkevi
  • Symkevi (tezacaftor/ivacaftor)
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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