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Displaying 61 - 80 of 295
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100383-PIP01-21
  • TRASTUZUMAB DERUXTECAN
  • Treatment of lung cancer
  • Enhertu
  • Enhertu
  • Enhertu
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
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-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-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-100565-PIP01-22
  • MDM2-p53 antagonist
  • Treatment of liposarcoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100555-PIP01-22
  • vepsitamab
  • Treatment of gastric cancer and gastro-oesophageal junction cancer
  • Treatment of colorectal carcinoma
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100583-PIP01-22
  • SACITUZUMAB GOVITECAN
  • Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)
  • Trodelvy
  • Trodelvy
  • Trodelvy
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100602-PIP01-22
  • monalizumab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100603-PIP01-22
  • Oleclumab
  • Treatment of lung cancer
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100598-PIP01-22
  • Cobolimab
  • Treatment of lung cancer
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100466-PIP01-22
  • zilovertamab vedotin
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)
  • not available at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100792-PIP01-22
  • OBINUTUZUMAB
  • Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies
  • Gazyvaro
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100719-PIP01-22
  • LUTETIUM (177LU) OXODOTREOTIDE
  • Treatment of gastroenteropancreatic neuroendocrine tumours
  • Lutathera 370 MBq/mL solution for infusion
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100740-PIP01-22
  • Xevinapant
  • Treatment of head and neck epithelial malignant neoplasms
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100788-PIP01-22
  • favezelimab
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Not availble at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023