Decision

Lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups

EAMS scientific opinion issued to Alnylam UK Limited for lumasiran in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 14 July 2020

Documents

Lumasiran: Public Assessment Report (PAR)

PDF, 138 KB, 3 pages

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Lumasiran: Treatment protocol: Information for healthcare professionals

PDF, 2.2 MB, 12 pages

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Lumasiran: Treatment protocol: Information for patients

PDF, 1.45 MB, 5 pages

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Lumasiran: Treatment protocol: Information on the Pharmacovigilance System

PDF, 2.64 MB, 3 pages

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Lumasiran: Information for NHS Medical Directors

PDF, 115 KB, 4 pages

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Details

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 Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.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

Published 14 July 2020