TOVANOR Inhalation powder, hard capsule Ref.[6836] Active ingredients: Glycopyrronium

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

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 ( ) printed in black below a black bar.

Qualitative and quantitative composition

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
Magnesium stearate

Pack sizes and marketing

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.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/12/790/001-008

Date of first authorisation: 28 September 2012
Date of latest renewal: 26 July 2017

Drugs

Drug Countries
TOVANOR Austria, Estonia, Spain, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, South Africa

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