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Displaying 1 - 20 of 426
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
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-100553-PIP01-22-M01 (update)
  • REMIMAZOLAM BESYLATE
  • Sedation
  • General Anaesthesia
  • Byfavo 20mg
  • Anerem
  • Byfavo
  • Byfavo
  • Byfavo
  • Anaesthesiology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100160-PIP01-21-M01 (update)
  • TOCILIZUMAB
  • Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy
  • RoActemra
  • RoActemra
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100203-PIP01-21-M01 (update)
  • Avacopan
  • Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
  • Tavneos
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 17/12/2021
MHRA-100093-PIP01-21-M01 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100086-PIP01-21-M01 (update)
  • UPADACITINIB
  • Treatment of atopic dermatitis
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100123-PIP01-21-M01 (update)
  • SARILUMAB
  • Treatment of chronic idiopathic arthritis
  • Kevzara
  • Kevzara
  • Kevzara
  • Kevzara
  • Kevzara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100321-PIP01-21-M01 (update)
  • GUSELKUMAB
  • Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100361-PIP01-21-M01 (update)
  • GOLIMUMAB
  • Treatment of ulcerative colitis
  • Simponi 50 mg solution for injection in pre-filled pen
  • Simponi 50 mg solution for injection in pre-filled syringe
  • Simponi 100 mg solution for injection in pre-filled pen
  • Simponi 45 mg/0.45 mL solution for injection in pre-filled pen
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100511-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of Crohn's disease
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100075-PIP01-21-M01 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
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-100443-PIP01-22-M01 (update)
  • BARICITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100518-PIP01-22-M01 (update)
  • APREMILAST
  • Treatment of Behçet’s Disease
  • Otezla
  • Otezla
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100517-PIP01-22-M01 (update)
  • APREMILAST
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Otezla
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100627-PIP01-22-M01 (update)
  • Liposomal ciclosporin A (L-CsA)
  • Treatment of bronchiolitis obliterans syndrome (BOS)
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100550-PIP01-22-M01 (update)
  • BELIMUMAB
  • Treatment of systemic lupus erythematosus
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100114-PIP01-21-M01 (update)
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100779-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100075-PIP01-21-M02 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Joenja
  • Joenja
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023