Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100, D-60318 Frankfurt/Main, Germany
Axura 10 mg film-coated tablets.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets.
Axura 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Axura 10 mg film-coated tablets: Pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings “1-0” on one side and “M M” on the other side. The tablet can be divided into equal doses. Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets: The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5’ on one side and imprint ‘MEM’ on the other side. The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings “1-0” on one side and “M M” on the other side. The tablet can be divided into equal doses. The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘15’ on one side and imprint ‘MEM’ on the other side. The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20’ on one side and imprint ‘MEM’ on the other side. Axura 20 mg film-coated tablets: Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and imprint “MEM” on the other side. |
Axura 10 mg film-coated tablets:
Each film-coated tablet contains 10mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets:
Each filmcoated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15mg memantine.
Each film-coated tablet contains 10mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Each film-coated tablet contains 15mg of memantine hydrochloride equivalent to 12.46mg memantine.
Each film-coated tablet contains 20mg of memantine hydrochloride equivalent to 16.62mg memantine.
Axura 20 mg film-coated tablets:
Each film-coated tablet contains 20mg of memantine hydrochloride equivalent to 16.62mg memantine.
For a 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 |
|---|
Axura 10 mg film-coated tabletsTablet core: Microcrystalline cellulose Tablet coating: Hypromellose Axura 5 mg+10 mg+15 mg+20 mg film-coated tabletsTablet cores for 5/10/15/20 mg film-coated tablets: Microcrystalline cellulose Tablet coating for 5/10/15/20 mg film-coated tablets: Hypromellose Additional for 10 mg film-coated tablets: Iron oxide yellow (E172) Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red (E172) Axura 20 mg film-coated tabletsTablet core: Microcrystalline cellulose Tablet coating: Hypromellose |
Axura 10 mg film-coated tablets:
Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/PP). Pack sizes of 14, 28, 30, 42, 50, 56, 98, 100, 112, and multipacks containing 840 (20 × 42), 980 (10 × 98) or 1000 (20 × 50) tablets are presented.
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets:
Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 filmcoated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg.
Axura 20 mg film-coated tablets:
Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip. Pack sizes of 14, 28, 42, 56, 98 or multipacks containing 840 (20 × 42) film-coated tablets are presented.
Not all pack sizes may be marketed.
Merz Pharmaceuticals GmbH, Eckenheimer Landstr. 100, D-60318 Frankfurt/Main, Germany
Axura 10 mg film-coated tablets:
EU/1/02/218/001
EU/1/02/218/002
EU/1/02/218/003
EU/1/02/218/007
EU/1/02/218/008
EU/1/02/218/009
EU/1/02/218/010
EU/1/02/218/012
EU/1/02/218/013
EU/1/02/218/014
EU/1/02/218/015
EU/1/02/218/030
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets:
EU/1/02/218/016
EU/1/02/218/023
Axura 20 mg film-coated tablets:
EU/1/02/218/017
EU/1/02/218/018
EU/1/02/218/019
EU/1/02/218/020
EU/1/02/218/021
EU/1/02/218/022
EU/1/02/218/024
EU/1/02/218/025
EU/1/02/218/026
EU/1/02/218/027
EU/1/02/218/028
EU/1/02/218/029
Date of first authorisation: 17 May 2002
Date of latest renewal: 17 May 2007
| Drug | Countries | |
|---|---|---|
| AXURA | Austria, Germany, Estonia, Spain, Croatia, Ireland, Lithuania, Poland |
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