Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
Ebixa 10 mg film-coated tablets.
Ebixa 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Ebixa 10 mg film-coated tablets: Pale yellow to yellow, oval shaped film-coated tablets with breaking line and imprint “1 0” on one side and “M M” on the other side. The tablet can be divided into equal doses. Ebixa 20 mg film-coated tablets: Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and “MEM” on the other side. |
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
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 |
|---|
|
Tablet cores for 10/20 mg film-coated tablets: Microcrystalline cellulose Tablet coat for 10/20 mg film-coated tablets: Hypromellose Additional for 10 mg film-coated tablets: Iron oxide yellow Additional for 20 mg film-coated tablets: Iron oxide yellow and red |
Blister: PVDC/PE/PVC/Al-blister or PP/Al-blister.
Ebixa 10 mg film-coated tablets:
Pack sizes of 14, 28, 30, 42, 50, 56, 70, 84, 98, 100,112 film-coated tablets.
Multipack containing 980 (10 packs of 98) and 1000 (20 packs of 50) film-coated tablets.
Perforated unit dose blister: PVDC/PE/PVC/Al-blister or PP/Al-blister.
Pack sizes 49 × 1, 56 × 1, 98 × 1 and 100 × 1 film-coated tablets.
Ebixa 20 mg film-coated tablets:
Pack sizes of 14, 28, 42, 56, 70, 84, 98, 112 film-coated tablets.
Multipack containing 840 (20 × 42) film-coated tablets.
Perforated unit dose blister: PVDC/PE/PVC/Al-blister or PP/Al-blister.
Pack sizes 49 × 1, 56 × 1, 98 × 1 and 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
EU/1/02/219/001-003
EU/1/02/219/007-012
EU/1/02/219/014-021
EU/1/02/219/023-035
EU/1/02/219/037-049
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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