Reason for request

Re-assessment of the Actual Benefit of all systemically administered

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Clinical Benefit

Substantial

Microcrystalline arthritis
The actual benefit of FLECTOR in this indication remains substantial.

Osteoarthritis
The actual benefit of FLECTOR in this indication remains substantial.

Radicular pain
The actual benefit of FLECTOR in this indication remains substantial.

Moderate

Extra-articular rheumatism such as scapulohumeral periarthritis, tendonitis and bursitis
The actual benefit of FLECTOR in these indications remains moderate.

Lumbar pain
The actual benefit of FLECTOR in this indication remains moderate.

Insufficient

Extra-articular rheumatism such as scapulohumeral periarthritis, tendonitis and bursitis
The actual benefit of FLECTOR in these indications remains insufficient in the subpopulation of patients who have risk factors for cardiovascular events.

Lumbar pain
The actual benefit of FLECTOR in this indication remains insufficient in the subpopulation of patients who have risk factors for cardiovascular events.

Microcrystalline arthritis
The actual benefit of FLECTOR in this indication remains insufficient in the subpopulation of patients who have risk factors for cardiovascular events.

Osteoarthritis
The actual benefit of FLECTOR in this indication remains insufficient in the subpopulation of patients who have risk factors for cardiovascular events.

Radicular pain
The actual benefit of FLECTOR in this indication remains insufficient in the subpopulation of patients who have risk factors for cardiovascular events.