Search Filters:

Displaying 241 - 260 of 1097
Download
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Download XLSX