Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
GoResp Digihaler 160 micrograms/4.5 micrograms inhalation powder.
| Pharmaceutical Form |
|---|
|
Inhalation powder. White powder. |
Each delivered dose (the dose that leaves the mouthpiece of the Digihaler) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
Excipient(s) with known effect: Each dose contains approximately 5 milligrams of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Budesonide |
Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers. |
|
| Eformoterol |
Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge. |
| List of Excipients |
|---|
|
Lactose monohydrate (may contain milk proteins) |
The inhaler is white with integrated electronics at the top and a semi-transparent wine red mouthpiece cover. The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP). Each inhaler contains 180 doses and is foilwrapped.
Pack sizes of 1, 2 or 3 inhalers.
Not all pack-sizes may be marketed.
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
EU/1/19/1403/001
EU/1/19/1403/002
EU/1/19/1403/003
Date of first authorisation: 3rd April 2020
| Drug | Countries | |
|---|---|---|
| GORESP DIGIHALER | Lithuania, United Kingdom |
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