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Reason for request
Modification of the wording of the indication in COPD permitting the treatment of patients with an FEV1 (measured before administration of a bronchodilator) of less than 60% of the predicted value and who have a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy.
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Clinical Benefit
| Moderate |
The actual benefit of SERETIDE DISKUS 500/50 μg per dose is moderate in this indication. |
Clinical Added Value
| no clinical added value |
SERETIDE DISKUS 500/50 μg/dose does not provide any improvement in actual benefit (level V) in the management of patients with COPD w ith a pre-bronchodilator FEV1 of < 60 % of the predicted value and a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy. |
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