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Displaying 201 - 220 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100806-PIP01-22
  • ALPELISIB
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
  • Piqray
  • Piqray
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100679-PIP01-22
  • Talazoparib
  • Treatment of Ewing Sarcoma
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2023
MHRA-100573-PIP01-22
  • Vorasidenib
  • Treatment of glioma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100840-PIP01-23
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100874-PIP01-23
  • PEMBROLIZUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100834-PIP01-23
  • SOTORASIB
  • Treatment of colorectal carcinoma
  • Lumykras
  • Lumykras
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100289-PIP01-21-M03 (update)
  • GALCANEZUMAB
  • Prevention of migraine headache
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101079-PIP01-23-M01 (update)
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  •  Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100352-PIP01-21-M02 (update)
  • AVAPRITINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100910-PIP01-23-M01 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Treatment of neuroblastoma
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100909-PIP01-23-M01 (update)
  • ABEMACICLIB
  • Treatment of Ewing's sarcoma.
  • Verzenios
  • Verzenios
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100993-PIP01-23-M01 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia (AML)
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100327-PIP01-21-M02 (update)
  • SELPERCATINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100409-PIP01-21-M01 (update)
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100934-PIP01-23-M01 (update)
  • CARFILZOMIB
  • Treatment of acute lymphoblastic leukaemia
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Kyprolis
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100985-PIP01-23-M01 (update)
  • BINIMETINIB
  • Treatment of melanoma
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100986-PIP01-23-M01 (update)
  • ENCORAFENIB
  • Treatment of melanoma
  • Braftovi
  • Braftovi
  • Bravtovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100866-PIP01-23
  • obecabtagene autoleucel
  • Treatment of acute lymphoblastic leukaemia (ALL)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/01/2024
MHRA-100950-PIP01-23
  • lutetium-177 (177Lu) rhPSMA 10.1
  • Treatment of prostate cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024