Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule (inhalation powder). Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( |
Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glycopyrronium |
Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate |
Tovanor Breezhaler is a single-dose inhaler. Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel. Each blister strip contains either 6 or 10 hard capsules.
PA/Alu/PVC – Alu perforated unit-dose blister
Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.
Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.
Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/12/790/001-008
Date of first authorisation: 28 September 2012
Date of latest renewal: 26 July 2017
| Drug | Countries | |
|---|---|---|
| TOVANOR | Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, South Africa |
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) printed in black below a black bar.