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Displaying 41 - 60 of 1128
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
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
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
MHRA-100303-PIP01-21-M03 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • COBICISTAT
  • DARUNAVIR ETHANOLATE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Symtuza
  • Symtuza
  • Symtuza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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
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
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
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
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
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
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
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
MHRA-101725-PIP01-24
  • GUSELKUMAB
  • Treatment of psoriasis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101687-PIP01-24-M01 (update)
  • MEPOLIZUMAB
  • Treatment of Hypereosinophilic Syndrome
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Nucala
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101677-PIP01-24
  • Rilvegostomig
  • Treatment of Lung Cancer Treatment of Biliary Tract Cancer
  • Rilvegostomig
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101690-PIP01-24
  • EMPAGLIFLOZIN
  • Derivative of 3‐phenyl‐3H,4H,6H,7H-pyrano[3,4‐d]imidazol‐4‐one (BI 690517)
  • Treatment of heart failure
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101546-PIP01-24
  • SECUKINUMAB
  • Treatment of vasculitides
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101243-PIP01-23
  • 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate
  • Major depressive disorder
  • Psychiatry
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101737-PIP01-24
  • GOZETOTIDE
  • Visualisation of prostate specific membrane antigen in prostate cancer
  • Isoprotrace
  • Isoprotrace 10 microgram, kit voor radiofarmaceutisch preparaat
  • Isoprotrace 10 Mikrogramm Kit für ein radioaktives Arzneimittel
  • Diagnostic
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101711-PIP01-24-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of C3 glomerulopathy
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Other: Complement-driven renal disease
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted