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Displaying 1 - 20 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-101619-PIP01-24
  • spesolimab
  • Treatment of hidradenitis suppurativa
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 10/03/2025
MHRA-101023-PIP01-23-M03 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
  • ZTALMY
  • ZTALMY
  • ZTALMY
  • ZTALMY
  • ZTALMY
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101283-PIP01-23-M02 (update)
  • Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues
  • Treatment of haemophilia A
  • Treatment of Haemophilia B
  • Fitusiran
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100376-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100635-PIP01-22-M02 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100799-PIP01-22-M02 (update)
  • BEDAQUILINE FUMARATE
  • Treatment of multi-drug resistant tuberculosis.
  • Sirturo
  • Sirturo
  • Sirturo
  • Sirturo
  • Sirturo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100507-PIP01-22-M03 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101723-PIP01-24-M01 (update)
  • USTEKINUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis).
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Selara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100216-PIP01-21-M04 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101016-PIP01-23-M01 (update)
  • ublituximab
  • Treatment of Multiple Sclerosis
  • Briumvi
  • Briumvi
  • Briumvi
  • Briumvi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101411-PIP01-24
  • Erdafitinib
  • Treatment of urothelial carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 10/03/2025
MHRA-101680-PIP01-24
  • CICLOSPORIN
  • Treatment of dry eye disease (DED)
  • Vevizye
  • Vevizye
  • Vevye
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 10/03/2025
MHRA-100315-PIP01-21-M01 (update)
  • Brensocatib
  • Treatment of non‐cystic fibrosis bronchiectasis
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100224-PIP02-22-M01 (update)
  • Etrasimod L-arginine
  • Treatment of Crohn's disease
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101622-PIP01-24
  • Derivative of azabicycloheptane-carboxamide
  • Treatment of bronchiectasis
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 10/03/2025
MHRA-101602-PIP01-24
  • navepegritide
  • Treatment of Achondroplasia
  • navepegritide
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 10/03/2025
MHRA-101491-PIP01-24-M01 (update)
  • UPADACITINIB
  • Treatment of Crohn's disease
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-100137-PIP01-21-M03 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/03/2025
MHRA-101354-PIP01-24
  • UPADACITINIB
  • Treatment of alopecia areata
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 10/03/2025
MHRA-101303-PIP01-23
  • OBINUTUZUMAB
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Gazyvaro
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 10/03/2025