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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
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-100951-PIP01-23-M03 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of Human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Infectious diseases
 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-100116-PIP01-21-M03 (update)
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
  • Treatment of Cystic Fibrosis
  • Kaftrio
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 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
MHRA-101250-PIP01-23-M01 (update)
  • RISANKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101107-PIP01-23-M01 (update)
  • BIRCH BARK EXTRACT
  • Treatment of epidermolysis bullosa
  • Filsuvez
  • Filsuvez gel
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101233-PIP01-23-M01 (update)
  • inebilizumab
  • Treatment of neuromyelitis optica spectrum disorders
  • Uplizna
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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