Displaying 661 - 680 of 1138
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100330-PIP01-21 -M02 (update)
  • Azamidugene autotemcel (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Not available at present
  • Other: Metabolic disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101336-PIP01-24-M02 (update)
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 3 SURFACE PROTEINS LIVE ATTENUATED
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 4 SURFACE PROTEINS LIVE ATTENUATED
  • Prevention of dengue fever
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga powder and solvent for solution for injection
  • Qdenga powder and solvent for solution for injection in pre-filled syringe
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Qdenga
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100525-PIP01-22-M02 (update)
  • TILDRAKIZUMAB
  • Treatment of psoriasis
  • Ilumetri
  • Ilumetri
  • Ilumetri
  • ILUMYA
  • ILUMYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
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
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
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-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-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-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-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