Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
Ebixa 5 mg/pump actuation oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. The solution is clear and colourless to light yellowish. |
Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Excipients with known effect: Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg potassium, see section 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Memantine |
Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. |
| List of Excipients |
|---|
|
Potassium sorbate |
50 ml (and 10 × 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III).
Not all pack sizes may be marketed.
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
EU/1/02/219/005-006
EU/1/02/219/013
Date of first authorisation: 15 May 2002
Date of latest renewal: 15 May 2007
| Drug | Countries | |
|---|---|---|
| EBIXA | Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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