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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101394-PIP01-24
  • clascoterone
  • Treatment of acne vulgaris
  • Winlevi 10 mg/g cream
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 24/06/2024
MHRA-101172-PIP01-23
  • Disitamab vedotin
  • Treatment of solid tumours including central nervous system malignancies
  • Aidixi
  • Aidixi
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101392-PIP01-24
  • Influenza Virus Type A, H1N1
  • Influenza Virus Type A, H3N2
  • Influenza Virus Type B, Victoria lineage
  • Prevention of influenza infection
  • Fluenz
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted 24/06/2024
MHRA-101103-PIP01-23
  • FINERENONE
  • Treatment of heart failure
  • Kerendia
  • Kerendia
  • Cardiovascular Diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101169-PIP01-23
  • vibostolimab
  • PEMBROLIZUMAB
  • Treatment of melanoma
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101235-PIP01-23
  • Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3
  • Treatment of achondroplasia
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101215-PIP01-23
  • Rocatinlimab
  • Treatment of prurigo nodularis
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101171-PIP01-23
  • ABBV-CLS-7262 Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)
  • Treatment of vanishing white matter disease
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/06/2024
MHRA-101298-PIP01-23
  • Ulviprubart
  • Treatment of inclusion body myositis
  • Not available at present
  • Immunology -Rheumatology-Transplantation
  • Other: Musculoskeletal disorders
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101277-PIP01-23
  • LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN)
  • LIVE ATTEN'D MUMPS VIRUS (RIT 4385 DERIVED FROM JERYL LYNN)
  • LIVE ATTENUATED RUBELLA (WISTAR RA 27/3 STRAIN)
  • Varicella virus Oka strain (live, attenuated)
  • Prevention of measles, mumps, rubella and varicella
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101156-PIP01-23
  • Cagrilintide
  • SEMAGLUTIDE
  • Type 2 Diabetes mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101265-PIP01-23
  • efgartigimod alfa
  • Treatment of thyroid eye disease
  • Vyvgar
  • Vyvgart
  • Vyvgart
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101226-PIP01-23
  • Volrustomig
  • Treatment of cervical cancer
  • Treatment of renal cell carcinoma
  • Treatment of lung cancer
  • Treatment of mesothelioma
  • Volrustomig
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101222-PIP01-23
  • SJP-0132
  • Treatment of Dry Eye Disease
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101093-PIP02-23
  • satralizumab
  • Treatment for thyroid eye disease (TED)
  • Enspryng
  • Enspryng
  • Enspryng
  • Neurology
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-100601-PIP01-22-M03 (update)
  • elasomeran
  • imelasomeran
  • DAVESOMERAN
  • ANDUSOMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB.1.5
  • Spikevax XBB1.5
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100564-PIP01-22-M03 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-101304-PIP01-23-M01 (update)
  • FILGOTINIB MALEATE
  • Treatment of ulcerative colitis
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-101249-PIP01-23-M01 (update)
  • Tovorafenib
  • Treatment of paediatric low grade glioma
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
MHRA-100197-PIP01-21-M02 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 01/05/2024
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