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Displaying 221 - 240 of 961
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100273-PIP03-24
  • Derivative of 6-[2-(pyridin-2- yl)phenoxy]methyl}- 1,2,3,4-tetrahydroisoquinoline
  • Treatment of portal hypertension
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-101342-PIP01-24-M01 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of major depressive disorder (MDD)
  • Spravato
  • Spravato
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101379-PIP01-24
  • Broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-101385-PIP01-24
  • Valemetostat tosilate
  • Treatment of mature T-cell neoplasms
  • EZHARMIA
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-100543-PIP01-22-M03 (update)
  • DOLUTEGRAVIR
  • LAMIVUDINE
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101073-PIP01-23-M02 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder.
  • BETMIGA
  • BETMIGA
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-101004-PIP01-23-M02 (update)
  • APIXABAN
  • Treatment of venous thromboembolism
  • Eliquis
  • Eliquis
  • Eliquis
  • Eliquis
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101123-PIP01-23-M02 (update)
  • BREXUCABTAGENE AUTOLEUCEL
  • Treatment of acute lymphoblastic leukaemia.
  • Tecartus
  • Brexucabtagene autoleucel
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100523-PIP01-22-M03 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100524-PIP01-22-M03 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100566-PIP01-22-M03 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100093-PIP01-21-M04 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis).
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100382-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of myasthenia gravis
  • Ultomiris
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100934-PIP01-23-M02 (update)
  • CARFILZOMIB
  • Treatment of acute lymphoblastic leukemia
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101302-PIP01-23-M01 (update)
  • BREXUCABTAGENE AUTOLEUCEL
  • Treatment of mature B-cell neoplasms
  • Brexucabtagene autoleucel
  • Brexucabtagene autoleucel
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101098-PIP01-23
  • Remibrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-100851-PIP01-23
  • NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • Recombinant Neisseria meningitidis serogroup B protein 1
  • Recombinant Neisseria meningitidis serogroup B protein 2
  • Recombinant Neisseria meningitidis serogroup B Protein-based active substance
  • Recombinant Neisseria meningitidis serogroup B protein 3
  • Prevention of meningococcal disease (serogroups A, B, C, W and Y)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
MHRA-100036-PIP01-21-M03 (update)
  • FERRIC MALTOL
  • Iron deficiency anaemia (IDA)
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • Accrufer
  • FERACCRU
  • FERACCRU
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101178-PIP01-23
  • 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol
  • Treatment of mastocytosis
  • Not available at present
  • Haematology-Hemostaseology
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-101256-PIP01-23-M01 (update)
  • RISANKIZUMAB
  • Treatment of ulcerative colitis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024