SIALANAR Oral solution Ref.[27652] Active ingredients: Glycopyrronium

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Proveca Pharma Limited, 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland

Product name and form

Sialanar 320 micrograms/ml oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless solution.

Qualitative and quantitative composition

Each ml contains 400 micrograms of glycopyrronium bromide equivalent to 320 micrograms of glycopyrronium.

Excipient(s) with known effect:

Each ml contains 2.3 mg sodium benzoate (E211).

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

Sodium benzoate (E211)
Raspberry flavouring (containing propylene glycol E1520)
Sucralose (E955)
Citric acid (E330)
Purified water

Pack sizes and marketing

Amber coloured glass bottle with a high density polyethylene tamper evident child resistant closure with expanded low density polyethylene liner. The bottle contains 60 ml or 250 ml of oral solution.

Pack size of one bottle, one 8 ml low density polyethylene oral syringe (0.1 ml graduations) and one syringe adaptor.

Not all pack sizes may be marketed.

Marketing authorization holder

Proveca Pharma Limited, 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland

Marketing authorization dates and numbers

EU/1/16/1135/001 (250 ml bottle)
EU/1/16/1135/002 (60 ml bottle)

Date of first authorisation: 15 September 2016
Date of latest renewal: 17 June 2021

Drugs

Drug Countries
SIALANAR Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

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