Decision

Lutetium (177Lu) vipivotide tetraxetan in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)

EAMS scientific opinion issued to Advanced Accelerator Applications for Lutetium (177Lu) vipivotide tetraxetan in the treatment of adults with a certain type of advanced prostate cancer that has spread to other parts of the body and that has already been treated with other anticancer treatments.

This publication was withdrawn on

Reason: Granting of marketing authorisation

Documents

Lutetium (177Lu) vipivotide tetraxetan: Public Assessment Report (PAR)

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Lutetium (177Lu) vipivotide tetraxetan: Treatment protocol: Information for patients

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Lutetium (177Lu) vipivotide tetraxetan: Treatment protocol: Information for healthcare professionals

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Lutetium (177Lu) vipivotide tetraxetan: Treatment protocol: Information on the Pharmacovigilance System

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Lutetium (177Lu) vipivotide tetraxetan: Information for NHS Medical Director

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Details

For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals.

The scientific opinion includes:

  • a public assessment report (PAR)
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
  • Information for NHS Medical Directors

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must register patients on the NHS England web-based registration system. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net.

For information about access in Northern Ireland, contact Chief Pharmaceutical Officer and secondary.care@health-ni.gov.uk.

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care at medicines.policy@gov.scot.

For information about access in Wales, contact the Welsh Government Health and Social Services Group by emailing Andrew Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of Pharmacy and Prescribing policy at Pharmacyand.PrescribingBranch@gov.wales

Updates to this page

Published 5 April 2022

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