SINGULAIR (montelukast), antileukotriene
Reason for request
Actual benefit unchanged in the treatment of asthma, except in children aged 6 to 24 months where it is low
- SINGULAIR, available in three dosage strengths (4 mg, 5 mg and 10 mg), has Marketing Authorisation:
- As an add-on to corticosteroid therapy in patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β2-agonists provide inadequate clinical control;
- In the prophylaxis of exercise-induced asthma;
- As an alternative treatment option to low-dose inhaled corticosteroids in patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (only SINGULAIR 4 mg for children aged 6 months to 5 years and 5 mg for children and adolescents aged 6 to 14 years).
- Its actual benefit remains substantial in all its indications except in children aged 6 to 24 months, where it remains low.