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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE …

European Medicines Agency Pre-authorisation Evaluation of Medicines for HUMAN Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged. London, 22 January 2009 Doc. Ref. CPMP/EWP/4151/00 Rev. 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) 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 DISCUSSION AT THE EFFICACY WORKING PARTY September 2000 TRANSMISSION TO CPMP January 2002 RELEASE FOR CONSULTATION January 2002 DEADLINE FOR COMMENTS April 2002 DISCUSSION AT THE EFFICACY WORKING PARTY January 2004 TRANSMISSION TO CPMP April 2004 ADOPTION BY CPMP April 2004 DATE FOR COMING INTO OPERATION O

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 . discussion at the efficacy working party . september 2000

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  Disease, Chronic, Obstructive, Pulmonary, Asthma, Asthma and chronic obstructive pulmonary disease

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