Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Onbrez Breezhaler 150 microgram inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
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Inhalation powder, hard capsule. Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above a black bar and company logo printed in black below the black bar. |
Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol.
The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol.
Excipient with known effect: Each capsule contains 24.8 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Indacaterol |
Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate Capsule shell: Gelatin |
Onbrez Breezhaler is a single-dose inhalation device. Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl methacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel.
PA/Alu/PVC – Alu blister containing 10 hard capsules.
Carton containing 10 capsules and one Onbrez Breezhaler inhaler. Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler).
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/09/593/001-005
Date of first authorisation: 30 November 2009
Date of latest renewal: 18 September 2014
| Drug | Countries | |
|---|---|---|
| ONBREZ BREEZHALER | Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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