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Displaying 121 - 140 of 651
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100148-PIP01-21-M01 (update)
  • LENVATINIB MESILATE
  • Treatment of all conditions included in the category of malignant neoplasms
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/12/2021
MHRA-100048-PIP01-21
  • Afamitresgene autoleucel
  • Treatment of soft tissue sarcoma
  • Not available at present.
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100084-PIP01-21-M01 (update)
  • MIDOSTAURIN
  • Treatment of acute myeloid leukaemia
  • Malignant mastocytosis
  • Mast cell leukaemia
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Rydapt® 25 mg soft capsules
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 18/03/2022
MHRA-100232-PIP01-21
  • ALECTINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Alecensa
  • Alecensa
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100291-PIP01-21
  • imetelstat
  • Treatment of acute myeloid leukaemia
  • Treatment of Myelodysplastic Syndromes (MDS), including JMML
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100254-PIP01-21
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100324-PIP01-21
  • Loncastuximab tesirine
  • Treatment of mature B-cell neoplasms
  • Zynlonta
  • Zynlonta
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100024-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100049-PIP01-21-M02 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100217-PIP01-21-M01 (update)
  • ERIBULIN
  • Treatment of soft tissue sarcoma
  • Halaven
  • Halaven
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100327-PIP01-21-M01 (update)
  • SELPERCATINIB
  • Treatment 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. Yes Partial Compliance Check Granted 17/05/2022
MHRA-100244-PIP01-21
  • surufatinib
  • Treatment of malignant neoplasms
  • Malignant neoplasms of haematopoietic and lymphoid tissue
  • Sevsury
  • Sulanda
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100117-PIP01-21-M01 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100145-PIP01-21-M01 (update)
  • BRIGATINIB
  • Non small cell lung cancer
  • Anaplastic large cell lymphoma
  • Inflammatory myofibroblastic tumours
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Alunbrig
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100166-PIP01-21-M01 (update)
  • ENTRECTINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100252-PIP01-21-M01 (update)
  • GEMTUZUMAB OZOGAMICIN
  • Treatment of acute myeloid leukaemia
  • Mylotarg
  • Mylotarg
  • 16/06/2019
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Mylotarg
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100494-PIP01-22-M01 (update)
  • NIVOLUMAB
  • Malignant neoplasms of lymphoid tissue
  • Malignant neoplasms of the central nervous system
  • OPDIVO
  • OPDIVO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100409-PIP01-21
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100335-PIP01-21
  • erdafitinib
  • Malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue)
  • BALVERSA
  • BALVERSA
  • ERFANDEL
  • BALVERSA
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100158-PIP01-21-M01 (update)
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Keytruda
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022