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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-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
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
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
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
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
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
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
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
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
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
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
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
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
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
MHRA-101581-PIP01-24
  • rinatabart sesutecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of peritoneal cancer.
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101573-PIP01-24
  • Trofinetide
  • Treatment of Rett syndrome
  • Not yet available in the United Kingdom (Daybu proposed in the EEA and currently being assessed)
  • Daybue
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101570-PIP01-24
  • firmonertinib
  • Treatment of non-small cell lung cancer (NSCLC)
  • firmonertinib
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101564-PIP01-24
  • (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084)
  • Treatment of all solid and haematological malignancies
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100046-PIP01-21-M05 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101540-PIP01-24
  • derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride
  • Treatment of psoriasis
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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