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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-100469-PIP01-22
  • delgocitinib
  • Treatment of chronic hand eczema
  • no invented name yet
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100482-PIP01-22
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of Niemann-Pick Disease type C (NPC)
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100572-PIP01-22
  • autologous bone marrow-derived mononuclear cell enriched white blood cells
  • Treatment of chronic limb-threatening ischemia
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100519-PIP01-22
  • RSV preF protein
  • Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100421-PIP01-22
  • efavaleukin alfa
  • Treatment of systemic lupus erythematosus (SLE)
  • Not available at present
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100519-PIP01-22
  • RSV preF protein
  • Prevention of lower respiratory tract disease caused by Respiratory syncytial virus (RSV)
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100087-PIP01-21-M02 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100418-PIP01-22-M01 (update)
  • axicabtagene ciloleucel
  • Treatment of mature B-cell neoplasms
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100695-PIP01-22-M01 (update)
  • Etranacogene dezaparvovec
  • Treatment of haemophilia B
  • Hemgenix
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M01 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100579-PIP01-22-M02 (update)
  • Maribavir
  • Treatment of cytomegalovius (CMV) infection
  • Livtencity
  • Livtencity
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100093-PIP01-21-M02 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100118-PIP01-21-M02 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100471-PIP01-22-M01 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • Nutrition
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100406-PIP01-21-M01 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100636-PIP01-22-M01 (update)
  • Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
  • Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV)
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100648-PIP01-22-M01 (update)
  • TECOVIRIMAT MONOHYDRATE
  • Treatment of orthopoxvirus disease (smallpox, monkeypox, cowpox, and vaccinia)
  • Tecovirimat SIGA
  • Tecovirimat SIGA
  • TPOXX
  • Infectious diseases
 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-100031-PIP01-21-M02 (update)
  • PALBOCICLIB
  • Treatment of Ewing sarcoma (EWS)
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • blisters in an outer carton/21 and 63 tablets
  • Ibrance
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
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