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Displaying 41 - 60 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-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-100396-PIP01-21
  • sugemalimab
  • Treatment of non-small cell lung cancer (NSCLC)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
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-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-100454-PIP01-22
  • adagrasib
  • Treatment of all solid and haematological malignancies
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100136-PIP01-21
  • PEMBROLIZUMAB
  • quavonlimab
  • All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100125-PIP01-21
  • PEMBROLIZUMAB
  • vibostolimab
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma)
  • Malignant CNS neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100069-PIP01-21
  • RIBOCICLIB
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100176-PIP01-21
  • favezelimab
  • PEMBROLIZUMAB
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid-tissue-& melanoma)
  • Neoplasms of CNS
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100246-PIP01-21
  • MK-1026
  • Treatment of mature B-cell malignancies
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100326-PIP01-21
  • GEMCITABINE HYDROCHLORIDE
  • Treatment of urothelial carcinoma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100311-PIP01-21
  • Cetrelimab
  • Treatment of urothelial carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100384-PIP01-21
  • datopotamab deruxtecan
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100385-PIP01-21
  • datopotamab deruxtecan
  • Treatment of breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100386-PIP01-21
  • patritumab deruxtecan
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100480-PIP01-22
  • (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide
  • Treatment of mature B-cell malignancies
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100516-PIP01-22
  • Toripalimab
  • Malignant neoplasms (except CNS, haematopoietic and lymphoid tissue and melanoma).
  • Not available at present
  • TUOYI
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/11/2022
MHRA-100401-PIP01-21
  • Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022