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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
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 24/06/2024
MHRA-101283-PIP01-23-M01 (update)
  • Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B.
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
MHRA-101093-PIP01-23-M01 (update)
  • satralizumab
  • Treatment of neuromyelitis optica.
  • Enspryng
  • Enspryng
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100283-PIP01-21-M03 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
MHRA-100209-PIP01-21-M01 (update)
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of obesity
  • Not available at present
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/06/2024
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