Atectura Breezhaler

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

indacaterol acetate, Mometasone furoate

Disponible depuis:

Novartis Europharm Limited 

Code ATC:

R03AK

DCI (Dénomination commune internationale):

indacaterol, mometasone

Groupe thérapeutique:

Drugs for obstructive airway diseases,

Domaine thérapeutique:

Asthma

indications thérapeutiques:

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.

Descriptif du produit:

Revision: 9

Statut de autorisation:

Authorised

Date de l'autorisation:

2020-05-30

Notice patient

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

Résumé des caractéristiques du produit

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