Decision

Glofitamab in the treatment of diffuse large B-cell lymphoma (DLBCL)

EAMS scientific opinion issued to Roche Products Limited for glofitamab as monotherapy in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

From:
Medicines and Healthcare products Regulatory Agency
Published
5 July 2023

This publication was withdrawn on

Withdrawn due to granting of marketing authorisation.

Documents

Glofitamab: Public Assessment Report (PAR)

PDF, 842 KB, 5 pages

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Glofitamab: Treatment protocol - Information for healthcare professionals

PDF, 315 KB, 19 pages

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Glofitamab: Treatment protocol - Information for patients

PDF, 227 KB, 9 pages

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Glofitamab: Information for NHS Medical Director

PDF, 134 KB, 4 pages

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Glofitimab: Treatment protocol Information on Pharmacovigilance system

PDF, 176 KB, 5 pages

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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
Published 5 July 2023