Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 41 - 60 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101244-PIP01-23
  • UPADACITINIB
  • Treatment of vitiligo
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-100999-PIP03-23
  • Ensitrelvir
  • Prevention of coronavirus disease 2019 (COVID-19).
  • Zokovea
  • Xocova
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101248-PIP01-23
  • UPADACITINIB
  • Treatment of systemic lupus erythematosus
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-100999-PIP02-23
  • Ensitrelvir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Zokovea
  • Xocova
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101091-PIP01-23
  • Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine (VLA15 - PF-07307405)
  • Prevention of Lyme disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-101049-PIP01-23
  • retifanlimab
  • Treatment of Merkel cell carcinoma
  • ZYNYZ
  • retifanlimab
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 11/02/2025
MHRA-100996-PIP01-23
  • GIPR antagonist/GLP-1R agonist- AMG 133
  • Treatment of obesity
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 11/02/2025
MHRA-100790-PIP01-22-M01 (update)
  • Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
  • Treatment of Duchenne muscular dystrophy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 11/02/2025
MHRA-101647-PIP01-24-M01 (update)
  • IXEKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)
  • Taltz
  • Taltz
  • Taltz
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 06/01/2025
MHRA-100348-PIP01-21-M02 (update)
  • botaretigene sparoparvovec
  • Treatment of retinitis pigmentosa
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101618-PIP01-24-M01 (update)
  • ADRENALINE
  • Treatment of allergic reactions
  • neffy
  • NEFFY
  • EURneffy
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/01/2025
MHRA-100479-PIP01-22-M03 (update)
  • POSACONAZOLE
  • Prevention of invasive fungal infections
  • Treatment of invasive fungal infections
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Noxafil
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-100252-PIP01-21-M02 (update)
  • GEMTUZUMAB OZOGAMICIN
  • Treatment of acute myeloid leukaemia
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101596-PIP01-24-M01 (update)
  • Ibrexafungerp
  • Treatment of vulvovaginal candidiasis
  • Prevention of recurrent vulvovaginal candidiasis
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 06/01/2025
MHRA-101588-PIP01-24
  • Derivative of 1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
MHRA-100084-PIP01-21-M03 (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 06/01/2025
MHRA-101587-PIP01-24-M01 (update)
  • CEFIDEROCOL SULFATE TOSYLATE
  • Treatment of infections due to aerobic Gram-negative bacteria
  • Fetcroja
  • Fetcroja
  • Fetroja
  • Fetcroja
  • Fetroja
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101586-PIP01-24
  • Ifinatamab deruxtecan
  • Treatment of lung cancer (small cell and non-small cell lung cancer)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
MHRA-101583-PIP01-24-M01 (update)
  • Recombinant Varicella Zoster Virus Glycoprotein E
  • Prevention of varicella zoster virus (VZV) reactivation
  • Shingrix
  • Shingrix
  • Shingrix
  • Shingrix
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-100920-PIP01-23-M01 (update)
  • Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae.
  • TBD
  • CAPVAXIVE®
  • CAPVAXIVE™
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 06/01/2025