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, tenofovir disoproxil fumarate (Viread®) cannot be endorsed for use within NHS Wales for the treatment of hepatitis B in paediatric patients aged 6 to < 12 years with compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis |
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Medicine details |
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| Medicine name | tenofovir disoproxil fumarate (Viread®) | |
| Formulation | 204 mg film-coated tablet, 163 mg film-coated tablet, 123 mg film-coated tablet, 33 mg/g granules for oral suspension | |
| Reference number | 3563 | |
| Indication | For the treatment of hepatitis B in paediatric patients aged 6 to < 12 years with compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis |
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| Company | Gilead Sciences Ltd | |
| BNF chapter | Infections | |
| Assessment type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Ratification by Welsh Government | 17/07/2019 | |
| Date of issue | 18/09/2019 | |