Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Aerius 0.5 mg/ml oral solution.
| Pharmaceutical Form |
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Oral solution is a clear, colourless solution. |
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 |
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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 |
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Sorbitol (E420) |
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.
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
EU/1/00/160/061-069
Date of first authorisation: 15 January 2001
Date of latest renewal: 9 February 2006
| 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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