Displaying 121 - 140 of 773
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100025-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100173-PIP01-21
  • PACLITAXEL
  • Treatment of soft tissue sarcoma
  • Paxorlea
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/11/2021
MHRA-100174-PIP01-21
  • Encequidar
  • Treatment of breast cancer
  • Treatment of soft tissue sarcoma
  • Paxorlea
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/11/2021
MHRA-100049-PIP01-21-M01 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • 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. No 17/11/2021
MHRA-100024-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100092-PIP01-21-M01 (update)
  • VENETOCLAX
  • Haematopoietic and lymphoid malignant neoplasms
  • Treatment of solid tumour malignant neoplasms
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100152-PIP01-21
  • cosibelimab
  • Treatment of cutaneous squamous cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/12/2021
MHRA-100131-PIP01-21
  • ATEZOLIZUMAB
  • Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
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-100142-PIP01-21
  • Synthetic Hypericin
  • Treatment of cutaneous T-cell lymphoma
  • HyBryte
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). 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-100112-PIP01-21
  • savolitinib
  • Treatment of renal neoplasms
  • Not available
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 18/03/2022
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-100368-PIP01-21
  • aumolertinib
  • Treatment of lung cancer
  • Ameile
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(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