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, tocilizumab (RoActemra®) cannot be endorsed for use within NHS Wales for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 years to < 2 years of age, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to methotrexate [MTX] or where treatment with MTX is inappropriate) or in combination with MTX |
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Medicine details |
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| Medicine name | tocilizumab (RoActemra®) | |
| Formulation | 62 mg subcutaneous injection | |
| Reference number | 2662 | |
| Indication | For the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 years to < 2 years of age, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to methotrexate [MTX] or where treatment with MTX is inappropriate) or in combination with MTX |
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| Company | Roche Products Ltd | |
| BNF chapter | Musculoskeletal & joint diseases | |
| Assessment type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Ratification by Welsh Government | 05/03/2019 | |
| Date of issue | 06/03/2019 | |