Following non-submission
AWMSG advice |
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Status: Not endorsed (Statement of Advice) | ||
In the absence of a submission from the holder of the marketing authorisation, temozolomide intravenous solution (Temodal®) cannot be endorsed for use within NHS Wales for the treatment of adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
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Medicine details |
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Medicine name | temozolomide (Temodal®) | |
Formulation | powder for solution for infusion | |
Reference number | 353 | |
Indication | For the treatment of adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
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Company | Merck Sharp & Dohme Ltd | |
BNF chapter | Malignant disease & immunosuppression | |
Submission type | Non-submission | |
Status | Not endorsed (Statement of Advice) | |
Ratification by Welsh Government | 11/10/2011 | |
Date of issue | 13/10/2011 |