AERIUS Oral solution Ref.[116343] Active ingredients: Desloratadine

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

Product name and form

Aerius 0.5 mg/ml oral solution.

Pharmaceutical Form

Oral solution is a clear, colourless solution.

Qualitative and quantitative composition

Each ml of oral solution contains 0.5 mg desloratadine.

Excipient(s) with known effect:

Each ml of oral solution contains 150 mg sorbitol (E420), 100.19 mg propylene glycol (E1520) and 0.375 mg benzyl alcohol (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient

Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine Η1-receptors because the substance is excluded from entry to the central nervous system.

List of Excipients

Sorbitol (E420)
Propylene glycol (E1520)
Sucralose (E955)
Hypromellose 2910
Sodium citrate dihydrate
Natural and artificial flavour (bubblegum, which contains propylene glycol (E1520) and benzyl alcohol)
Citric acid anhydrous
Disodium edetate
Purified water

Pack sizes and marketing

Aerius oral solution, is supplied in 30, 50, 60, 100, 120, 150, 225 and 300 ml size Type III amber glass bottles closed with a plastic child resistant (C/R) screw closure having a multi-ply polyethylene-faced liner. All packages except the 150 ml package are supplied with a measuring spoon marked for doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

Marketing authorization dates and numbers

EU/1/00/160/061-069

Date of first authorisation: 15 January 2001
Date of latest renewal: 9 February 2006

Drugs

Drug Countries
AERIUS Austria, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey

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