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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100260-PIP01-21-M01 (update)
  • CEMIPLIMAB
  • Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Libtayo
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100233-PIP01-21-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Aptimetyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100377-PIP01-21-M01 (update)
  • ACALABRUTINIB
  • Treatment of mature B cell neoplasms
  • calquence
  • calquence
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100352-PIP01-21-M01 (update)
  • AVAPRITINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. 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-100200-PIP01-21-M01 (update)
  • REGORAFENIB
  • Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Stivarga
  • Stivarga
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/11/2022
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
MHRA-100455-PIP01-22-M01 (update)
  • IXAZOMIB
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
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
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