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SINGULAIR (montelukast), antileukotriene

Opinions on drugs - Posted on Mar 11 2016

Reason for request

Renewal of Inclusion

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.

Clinical Benefit




Therapeutic use


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