Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
Xyzal 0.5 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear and colourless solution. |
1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride.
Excipients with known effect:
0.675 mg methyl parahydroxybenzoate/ml
0.075 mg propyl parahydroxybenzoate/ml
0.4 g maltitol liquid/ml
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levocetirizine |
Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate (for pH adjustment) Tutti frutti flavor contains: |
Type III amber glass bottle closed with a white polypropylene child-resistant closure in a cardboard box also containing a 10 ml oral syringe graduated at 0.25 ml (polyethylene, polystyrene).
Pack sizes: 75 ml, 150 ml and 200 ml.
Not all pack sizes may be marketed.
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
PL 00039/731
Date of first authorisation: 21-Mar-2007
Date of latest renewal: 06-Oct-2014
| Drug | Countries | |
|---|---|---|
| XYZAL | Austria, Cyprus, Estonia, Finland, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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