Displaying 41 - 60 of 887
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100523-PIP01-22-M03 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100524-PIP01-22-M03 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
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 15/08/2024
MHRA-100093-PIP01-21-M04 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis).
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
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 15/08/2024
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 15/08/2024
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 15/08/2024
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 15/08/2024
MHRA-100851-PIP01-23
  • NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • Recombinant Neisseria meningitidis serogroup B protein 1
  • Recombinant Neisseria meningitidis serogroup B protein 2
  • Recombinant Neisseria meningitidis serogroup B Protein-based active substance
  • Recombinant Neisseria meningitidis serogroup B protein 3
  • Prevention of meningococcal disease (serogroups A, B, C, W and Y)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
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 15/08/2024
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 15/08/2024
MHRA-101256-PIP01-23-M01 (update)
  • RISANKIZUMAB
  • Treatment of ulcerative colitis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/08/2024
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 15/08/2024
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 15/08/2024
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 15/08/2024
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 25/06/2024
MHRA-100084-PIP01-21-M02 (update)
  • MIDOSTAURIN
  • Treatment of acute myeloid leukaemia
  • Treatment of malignant mastocytosis
  • Treatment of mast cell leukaemia.
  • Rydapt
  • Rydapt
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-101336-PIP01-24-M01 (update)
  • DENGUE VIRUS SEROTYPE 2 EXPRESSING DENGUE VIRUS SEROTYPE 1 SURFACE PROTEINS 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
  • DENGUE VIRUS SEROTYPE 2 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
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
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 24/06/2024
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 24/06/2024