|Agency product number||
|International non-proprietary name (INN) or common name||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
25/07/2017 Orencia - EMEA/H/C/000701 - II/0105
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Rheumatoid arthritisORENCIA, in combination with methotrexate, is indicated for:
- the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
- the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.