Country: European Union
Language: English
Source: EMA (European Medicines Agency)
indacaterol acetate, Mometasone furoate
Novartis Europharm Limited
R03AK
indacaterol, mometasone
Drugs for obstructive airway diseases,
Asthma
Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.
Revision: 9
Authorised
2020-05-30
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 62.5 mcg of mometasone furoate. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 127.5 mcg of mometasone furoate. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 260 mcg of mometasone furoate. Excipient(s) with known effect Each capsule contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powd Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 62.5 mcg of mometasone furoate. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 127.5 mcg of mometasone furoate. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 260 mcg of mometasone furoate. Excipient(s) with known effect Each capsule contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powd Read the complete document