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Displaying 141 - 160 of 1015
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
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
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
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
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
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
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
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
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
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
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
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
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
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
MHRA-100492-PIP01-22-M02 (update)
  • MOLGRAMOSTIM
  • Treatment of pulmonary alveolar proteinosis
  • MOLBREEVI
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101521-PIP01-24
  • Derivative of 6-(piperidine-1-carbonyl)pyridine-3-ol
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101506-PIP01-24
  • Zongertinib
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101482-PIP01-24-M01 (update)
  • BELATACEPT
  • Prevention of rejection of transplanted kidney
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • NULOJIX
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100247-PIP01-21-M02 (update)
  • BEROTRALSTAT DIHYDROCHLORIDE
  • Treatment of hereditary angioedema
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Orladeyo
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101489-PIP01-24
  • Enlicitide (decanoate)
  • Treatment of hypercholesterolemia
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No