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Displaying 241 - 260 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
PIP Number MHRA-100823-PIP01-22-M02 (update) Active Substance
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
Conditions / Indications
  • Treatment of thrombotic thrombocytopenic purpura.
Invented Name
  • Not available at present
Therapeutic area
  • Haematology-Hemostaseology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101359-PIP01-24 Active Substance
  • spesolimab
Conditions / Indications
  • Treatment of Netherton syndrome
Invented Name
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
Therapeutic area
  • Dermatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101021-PIP01-23-M01 (update) Active Substance
  • FILGOTINIB
Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)
Invented Name
  • Jyseleca
  • Jyseleca
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100273-PIP03-24 Active Substance
  • Derivative of 6-[2-(pyridin-2- yl)phenoxy]methyl}- 1,2,3,4-tetrahydroisoquinoline
Conditions / Indications
  • Treatment of portal hypertension
Invented Name
  • Not available at present
Therapeutic area
  • Gastroenterology-Hepatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101342-PIP01-24-M01 (update) Active Substance
  • ESKETAMINE HYDROCHLORIDE
Conditions / Indications
  • Treatment of major depressive disorder (MDD)
Invented Name
  • Spravato
  • Spravato
Therapeutic area
  • Psychiatry
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101379-PIP01-24 Active Substance
  • Broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)
Conditions / Indications
  • Treatment of human immunodeficiency virus (HIV-1) infection
Invented Name
  • Not available at present
Therapeutic area
  • Infectious diseases
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101385-PIP01-24 Active Substance
  • Valemetostat tosilate
Conditions / Indications
  • Treatment of mature T-cell neoplasms
Invented Name
  • EZHARMIA
Therapeutic area
  • Oncology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100543-PIP01-22-M03 (update) Active Substance
  • DOLUTEGRAVIR
  • LAMIVUDINE
Conditions / Indications
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
Invented Name
  • Dovato
  • Dovato
  • Dovato
Therapeutic area
  • Infectious diseases
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101073-PIP01-23-M02 (update) Active Substance
  • MIRABEGRON
Conditions / Indications
  • Treatment of idiopathic overactive bladder.
Invented Name
  • BETMIGA
  • BETMIGA
Therapeutic area
  • Uro-Nephrology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101004-PIP01-23-M02 (update) Active Substance
  • APIXABAN
Conditions / Indications
  • Treatment of venous thromboembolism
Invented Name
  • Eliquis
  • Eliquis
  • Eliquis
  • Eliquis
Therapeutic area
  • Cardiovascular Diseases
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101123-PIP01-23-M02 (update) Active Substance
  • BREXUCABTAGENE AUTOLEUCEL
Conditions / Indications
  • Treatment of acute lymphoblastic leukaemia.
Invented Name
  • Tecartus
  • Brexucabtagene autoleucel
Therapeutic area
  • Oncology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100523-PIP01-22-M03 (update) Active Substance
  • gadopiclenol
Conditions / Indications
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
Invented Name
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
Therapeutic area
  • Diagnostic
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100524-PIP01-22-M03 (update) Active Substance
  • gadopiclenol
Conditions / Indications
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
Invented Name
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
Therapeutic area
  • Diagnostic
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100566-PIP01-22-M03 (update) Active Substance
  • MIRABEGRON
Conditions / Indications
  • Treatment of neurogenic detrusor overactivity
Invented Name Therapeutic area
  • Uro-Nephrology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100093-PIP01-21-M04 (update) Active Substance
  • UPADACITINIB
Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis).
Invented Name
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100382-PIP01-21-M01 (update) Active Substance
  • RAVULIZUMAB
Conditions / Indications
  • Treatment of myasthenia gravis
Invented Name
  • Ultomiris
Therapeutic area
  • Neurology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100934-PIP01-23-M02 (update) Active Substance
  • CARFILZOMIB
Conditions / Indications
  • Treatment of acute lymphoblastic leukemia
Invented Name
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Kyprolis
Therapeutic area
  • Oncology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101302-PIP01-23-M01 (update) Active Substance
  • BREXUCABTAGENE AUTOLEUCEL
Conditions / Indications
  • Treatment of mature B-cell neoplasms
Invented Name
  • Brexucabtagene autoleucel
  • Brexucabtagene autoleucel
Therapeutic area
  • Oncology
Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101098-PIP01-23 Active Substance
  • Remibrutinib
Conditions / Indications
  • Treatment of Multiple Sclerosis
Invented Name Therapeutic area
  • Neurology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100851-PIP01-23 Active Substance
  • 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
Conditions / Indications
  • Prevention of meningococcal disease (serogroups A, B, C, W and Y)
Invented Name Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending