Reason for request

Re-assessment of the Actual Benefit of all systemically administered

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Clinical Benefit

Substantial

VOLTARENE 25 mg, 50 mg, LP 75 mg, LP 100 mg
The actual benefit of these proprietary medicinal products remains substantial in the treatment of :

• chronic inflammatory rheumatic diseases, particularly rheumatoid arthritis, ankylosing spondylitis or related syndromes such as Reiter’s syndrome, and psoriatic arthritis ;

• severe radicular pain ;

• microcrystalline arthritis ;

• juvenile inflammatory rheumatic diseases ;

• osteoarthritis ;

• primary dysmenorrhoea, after aetiological assessment ;

VOLTARENE 75 mg/3 ml, solution for IM injection
The actual benefit of this proprietary medicinal product remains substantial in renal colics.

Moderate

VOLTARENE 25 mg, 50 mg, LP 75 mg, LP 100 mg
The actual benefit of these proprietary medicinal products remains moderate in abarticular rheumatism and lumbar pain.

VOLTARENE ENFANT, suppository
The actual benefit of this proprietary medicinal product in its indications remains moderate.

VOLTARENE 100 mg, suppository
The actual benefit of this proprietary medicinal product in its indications remains moderate.

VOLTARENE 75 mg/3 ml, solution for IM injection
The actual benefit of this proprietary medicinal product remains moderate in episodes of inflammatory rheumatic disease, acute lumbar pain and radicular pain.

Insufficient

VOLTARENE 25 mg, 50 mg, LP 75 mg, LP 100 mg
The actual benefit of these proprietary medicinal products is insufficient in the subpopulation of patients who have risk factors for cardiovascular event.

VOLTARENE ENFANT, suppository
The actual benefit of these proprietary medicinal products is insufficient in the subpopulation of children who could have risk factors for cardiovascular event.

VOLTARENE 100 mg, suppository
The actual benefit of these proprietary medicinal products is insufficient in the subpopulation of patients who have risk factors for cardiovascular event.

VOLTARENE 75 mg/3 ml, solution for IM injection
The actual benefit of these proprietary medicinal products is insufficient in the subpopulation of patients who have risk factors for cardiovascular events.