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Displaying 1 - 20 of 107
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100029-PIP01-21-M01 (update)
  • RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE
  • COVID-19 vaccine (Ad26.COV2-S [recombinant])
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Jcovden (previously COVID-19 Vaccine Janssen)
  • Infectious diseases
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100081-PIP01-21
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Other: Renal Disease
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100035-PIP01-21
  • POVIDONE-IODINE
  • ISOPROPYL ALCOHOL
  • Prevention of infection prior to invasive procedures
  • PurPrep
  • Other: Antiseptic
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022
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-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-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-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-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-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-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-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