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, pegvaliase (Palynziq®) cannot be endorsed for use within NHS Wales for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. |
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Medicine details |
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| Medicine name | pegvaliase (Palynziq®) | |
| Formulation | 2.5 mg solution for injection, 10 mg solution for injection, 20 mg solution for injection | |
| Reference number | 3097 | |
| Indication | For the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. |
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| Company | BioMarin International Ltd | |
| BNF chapter | Nutrition & blood | |
| Submission type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Ratification by Welsh Government | 16/09/2019 | |
| Date of issue | 18/09/2019 | |