Guideline on the requirements for clinical documentation for orally inhaled Products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in adults and for use in the treatment of Asthma in children and adolescents - European Medicines Agency, Committee for medical products for human use (CHMP)
London, 22 January 2009 Doc. Ref. CPMP/EWP/4151/00 Rev. 1