Displaying 481 - 500 of 959
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101362-PIP01-24-M01 (update)
  • ZANAMIVIR
  • Prevention of influenza
  • Treatment of influenza
  • Relenza (inhalation powder)
  • Dectova (solution for infusion)
  • Dectova
  • Dectova
  • Relenza
  • Relenza
  • Relenza
  • Relenza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101360-PIP01-24-M01 (update)
  • Purified Rabies virus, WISTAR PM/WI 38-1503-3M strain (inactivated)
  • Prevention of rabies viral infection
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101359-PIP01-24
  • spesolimab
  • Treatment of Netherton syndrome
  • 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-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-100543-PIP01-22-M03 (update)
  • DOLUTEGRAVIR
  • LAMIVUDINE
  • Treatment of Human Immunodeficiency virus type 1 (HIV-1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. 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-101098-PIP01-23
  • Remibrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100036-PIP01-21-M03 (update)
  • FERRIC MALTOL
  • Iron deficiency anaemia (IDA)
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • Accrufer
  • FERACCRU
  • FERACCRU
  • Haematology-Hemostaseology
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-100654-PIP01-22
  • triheptanoin
  • Treatment of long-chain fatty acid oxidation disorders (LC-FAOD)
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
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