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, ledipasvir / sofosbuvir (Harvoni®) cannot be endorsed for use within NHS Wales for the treatment of chronic hepatitis C (CHC) in paediatric patients aged 3 to < 18 years and weighing above 17kg. |
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Medicine details |
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| Medicine name | ledipasvir / sofosbuvir (Harvoni®) | |
| Formulation | 45 mg / 200 mg film-coated tablets, 90 mg / 200 mg film-coated tablets, 33.75 mg / 150 mg coated granules, 45 mg / 200 mg coated granules | |
| Reference number | 4588 | |
| Indication | Treatment of chronic hepatitis C (CHC) in paediatric patients aged 3 to < 18 years and weighing above 17kg |
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| Company | Gilead Sciences Ltd | |
| BNF chapter | Infections | |
| Assessment type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Date of issue | 23/07/2021 | |