Displaying 641 - 660 of 1030
Download
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100273-PIP03-24
  • Derivative of 6-[2-(pyridin-2- yl)phenoxy]methyl}- 1,2,3,4-tetrahydroisoquinoline
  • Treatment of portal hypertension
  • Not available at present
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101379-PIP01-24
  • Broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Not available at present
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101385-PIP01-24
  • Valemetostat tosilate
  • Treatment of mature T-cell neoplasms
  • EZHARMIA
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101073-PIP01-23-M02 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder.
  • BETMIGA
  • BETMIGA
  • Uro-Nephrology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101004-PIP01-23-M02 (update)
  • APIXABAN
  • Treatment of venous thromboembolism
  • Eliquis
  • Eliquis
  • Eliquis
  • Eliquis
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101123-PIP01-23-M02 (update)
  • BREXUCABTAGENE AUTOLEUCEL
  • Treatment of acute lymphoblastic leukaemia.
  • Tecartus
  • Brexucabtagene autoleucel
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100566-PIP01-22-M03 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100382-PIP01-21-M01 (update)
  • RAVULIZUMAB
  • Treatment of myasthenia gravis
  • Ultomiris
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100934-PIP01-23-M02 (update)
  • CARFILZOMIB
  • Treatment of acute lymphoblastic leukemia
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101302-PIP01-23-M01 (update)
  • BREXUCABTAGENE AUTOLEUCEL
  • Treatment of mature B-cell neoplasms
  • Brexucabtagene autoleucel
  • Brexucabtagene autoleucel
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101178-PIP01-23
  • 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol
  • Treatment of mastocytosis
  • Not available at present
  • Haematology-Hemostaseology
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100724-PIP01-22
  • tozorikamab
  • Treatment of severe viral lower respiratory tract infection
  • Pneumology - Allergology
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100723-PIP01-22
  • Wisconsin modRNA (PF-07829855)
  • Austria modRNA (PF-07872963)
  • Darwin modRNA (PF-07871853)
  • Phuket modRNA (PF-07836259)
  • Prevention of influenza disease
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101286-PIP01-23
  • Varicella virus Oka strain (live, attenuated)
  • Prevention of varicella
  • Not Applicable
  • Infectious diseases
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100754-PIP01-22-M01 (update)
  • Live-attenuated La Reunion strain of chikungunya virus
  • Prevention of chikungunya virus disease
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101289-PIP01-23-M01 (update)
  • Remibrutinib
  • Treatment of chronic spontaneous urticaria.
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100364-PIP01-21-M01 (update)
  • Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Arexvy
  • Arexvy
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101352-PIP01-24-M01 (update)
  • Autologous tumour-infiltrating lymphocytes (LN-144/LN-145)
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AMTAGVI
  • AMTAGVI
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101097-PIP01-23-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, mpox and related orthopoxvirus infection and disease
  • Imvanex
  • Imvanex
  • Imvamune
  • Jynneos
  • Imvanex
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100604-PIP01-22-M02 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
Download XLSX