Displaying 161 - 180 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100366-PIP01-21
  • Cevostamab
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100365-PIP01-21
  • Batiraxcept
  • 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 07/12/2022
MHRA-100481-PIP01-22
  • TUCATINIB
  • Treatment of solid tumours
  • Tukysa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100148-PIP01-21-M02 (update)
  • LENVATINIB MESILATE
  • Malignant neoplasms except haematopoietic, lymphoid, papillary & follicular thyroid, &osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100522-PIP01-22-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cometriq
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100501-PIP01-22-M01 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100623-PIP01-22-M01 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100254-PIP01-21-M01 (update)
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100458-PIP01-22
  • Modakafusp alfa
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100418-PIP01-22-M01 (update)
  • axicabtagene ciloleucel
  • Treatment of mature B-cell neoplasms
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Yescarta
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100031-PIP01-21-M02 (update)
  • PALBOCICLIB
  • Treatment of Ewing sarcoma (EWS)
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • blisters in an outer carton/21 and 63 tablets
  • Ibrance
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100442-PIP01-22-M01 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100025-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023
MHRA-100472-PIP01-22
  • Tarlatamab
  • Treatment of small cell lung cancer (SCLC)
  • Treatment of prostate malignant neoplasms.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100634-PIP01-22
  • Ceralasertib
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100345-PIP01-21
  • Magrolimab
  • Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia)
  • Treatment of acute myeloid leukaemia
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100545-PIP01-22
  • Lutetium (177Lu) edotreotide
  • Treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100485-PIP01-22-M01 (update)
  • AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide
  • Treatment of acute myeloid leukaemia
  • Tapotoclax
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100505-PIP01-22-M01 (update)
  • copanlisib dihydrochloride
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Treatment of mature B-cell neoplasms
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023