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Displaying 81 - 100 of 961
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100254-PIP01-21-M02 (update)
  • epcoritamab
  • Treatment of mature B-cell lymphoma
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101388-PIP01-24-M02 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia
  • QUVIVIQ
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100079-PIP01-21-M04 (update)
  • GILTERITINIB FUMARATE
  • Treatment of acute myeloid leukaemia (AML)
  • Xospata
  • Xospata
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101572-PIP01-24
  • Nogapendekin alfa
  • Inbakicept
  • Treatment of malignant bladder neoplasms
  • ANKTIVA
  • ANKTIVA
  • Uro-Nephrology
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/11/2024
MHRA-100412-PIP01-22-M03 (update)
  • vadadustat
  • Treatment of anaemia due to chronic disorders
  • VAFSEO
  • VAFSEO
  • Haematology-Hemostaseology
  • Other: Anti-anaemic preparations
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100149-PIP01-21-M03 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101465-PIP01-24
  • anitocabtagene autoleucel
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/11/2024
MHRA-101547-PIP01-24
  • IgG-like T cell engager binding to DLL3 and CD3
  • Treatment of small cell lung carcinoma
  • Treatment of neuroendocrine carcinoma, (excluding neuroblastoma)
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/11/2024
MHRA-100524-PIP01-22-M04 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100523-PIP01-22-M04 (update)
  • gadopiclenol
  • Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes.
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Elucirem
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101516-PIP01-24-M01 (update)
  • FLUTICASONE FUROATE
  • VILANTEROL TRIFENATATE
  • Treatment of asthma
  • Relvar Ellipta
  • BREO ELLIPTA
  • BREO ELLIPTA
  • Relvar Ellipta
  • RELVARE
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • BREO ELLIPTA
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • Relvar Ellipta
  • BREO ELLIPTA
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100238-PIP01-21-M02 (update)
  • AVELUMAB
  • Treatment of malignant neoplasms of the central nervous system
  • Treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the lymphoid tissue.
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-100916-PIP01-23-M02 (update)
  • ELUXADOLINE
  • Treatment of diarrhoea-predominant irritable bowel syndrome
  • Viberzi
  • Viberzi
  • Viberzi
  • Viberzi
  • Truberzi
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101422-PIP02-24
  • single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B and the N terminal domain (NTD) and receptor binding domain (RBD) of the SARS-CoV-2 spike glycoprotein.
  • (mRNA-1083)
  • Prevention of influenza and coronavirus disease 2019 (COVID-19)
  • NA
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-101467-PIP01-24
  • apitegromab
  • Treatment of spinal muscular atrophy
  • Other: Neuromuscular disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-101445-PIP01-24
  • CANNABIDIOL
  • Treatment of fragile X syndrome
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-100558-PIP01-22-M01 (update)
  • milvexian
  • Prevention of thromboembolism in patients with cardiovascular diseases
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/11/2024
MHRA-101486-PIP01-24
  • Avalotcagene Ontaparvovec
  • Treatment of ornithine transcarbamylase deficiency
  • Not Yet Available
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/11/2024
MHRA-101523-PIP01-24
  • Raludotatug deruxtecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of primary peritoneal cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 28/11/2024
MHRA-101497-PIP01-24
  • laruparetigene zovaparvovec
  • Recombinant Adeno-Associated Viral Vector Expressing a Human RPGR1-14,ORF15gene (rAAV2tYF-GRK1-RPGR)
  • Treatment of X-linked retinitis pigmentosa (XLRP)
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 28/11/2024