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Displaying 141 - 160 of 385
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100681-PIP01-22
  • Lomitapide
  • Treatment of (heterozygous or homozygous) familial hypercholesterolaemia
  • Lojuxta hard capsule
  • Other: Hypercholesterolaemia (HoFH)
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100727-PIP01-22-M01 (update)
  • ALPELISIB
  • Treatment of PIK3CA related overgrowth spectrum
  • Vijoice
  • Piqray
  • Vijoice
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100805-PIP01-22-M01 (update)
  • ATIDARSAGENE AUTOTEMCEL
  • Treatment of metachromatic leukodystrophy (MLD)
  • Libmeldy
  • Libmeldy
  • Libmeldy
  • Other: Lysosomal storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100750-PIP01-22-M01 (update)
  • setrusumab
  • Treatment of osteogenesis imperfecta
  • Other: Skeletal
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100330-PIP01-21 -M01 (update)
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Not available at present
  • Other: Metabolic disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100130-PIP01-21-M01 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100130-PIP01-21-M02 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100023-PIP01-21-M01 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100090-PIP01-21-M01 (update)
  • DUPILUMAB
  • Treatment of atopic dermatitis
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100276-PIP01-21-M01 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • brodalumab
  • Lumicef
  • Siliq
  • Kyntheum
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/05/2022
MHRA-100216-PIP01-21-M01 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralaza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100264-PIP01-21-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100426-PIP01-22-M01 (update)
  • ligelizumab
  • Treatment of chronic spontaneous urticaria
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100188-PIP01-21-M01 (update)
  • lebrikizumab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100221-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of atopic dermatitis
  • Olumiant
  • Olumiant
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100525-PIP01-22-M01 (update)
  • TILDRAKIZUMAB
  • Treatment of psoriasis
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • ILUMYA
  • ILUMYA
  • ILUMYA
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100216-PIP01-21-M02 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100297-PIP01-21
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (AMG 451)
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100023-PIP01-21-M02 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100463-PIP01-22-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023