PANPHARMA METHACHOLINE CHLORIDE (methacholine chloride) - Diagnostic of bronchial hyperreactivity

The Committee deems that the clinical benefit of PANPHARMA METHACHOLINE CHLORIDE 100 mg, powder for solution for inhalation by nebulisation (methacholine chloride), is moderate in the MA indication.

In view of:

• the use of methocholine for several decades for the diagnosis of non-specific bronchial hyperreactivity in adults and children (at least 5 years old), who are capable of performing reproducible spirometry, whose spirometry is normal and who do not present with clinically apparent asthma, but who have medical history suggesting this condition;
• the evidence of the efficacy of methacholine based on bibliographic data;
• the poor robustness of the findings of the clinical studies linked with the methodological limitations of the studies provided;
• the good safety profile of methacholine;
• the partially met medical need;

the Committee deems that PANPHARMA METHACHOLINE CHLORIDE 100 mg, powder for solution for inhalation by nebulisation (methacholine chloride), provides no clinical added value (CAV V) in the current diagnostic strategy in respect of bronchial hyperreactivity.