Active ingredients: Aripiprazole
ABILIFY 5 mg tablets.
ABILIFY 10 mg tablets.
ABILIFY 15 mg tablets.
ABILIFY 30 mg tablets.
Tablet.
ABILIFY 5 mg tablets: Rectangular and blue, engraved with “A-007” and “5” on one side.
ABILIFY 10 mg tablets: Rectangular and pink, engraved with “A-008” and “10” on one side.
ABILIFY 15 mg tablets: Round and yellow, engraved with “A-009” and “15” on one side.
ABILIFY 30 mg tablets: Round and pink, engraved with “A-011” and “30” on one side.
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 67 mg lactose per tablet.
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect: 62.18 mg lactose per tablet.
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect: 57 mg lactose per tablet.
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect: 186.54 mg lactose per tablet.
For the full list of excipients, see section 6.1.
It has been proposed that aripiprazole’s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.
Tablet core:
Lactose monohydrate
Maize starch
Microcrystalline cellulose
Hydroxypropyl cellulose
Magnesium stearate
Tablet coat:
ABILIFY 5 mg tablets:
Indigo carmine aluminium lake (E132)
ABILIFY 10 mg tablets:
Red iron oxide (E172)
ABILIFY 15 mg tablets:
Yellow iron oxide (E172)
ABILIFY 30 mg tablets:
Red iron oxide (E172)
Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets.
Not all pack sizes may be marketed.
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
ABILIFY 5 mg tablets:
EU/1/04/276/001 (5 mg, 14 × 1 tablets)
EU/1/04/276/002 (5 mg, 28 × 1 tablets)
EU/1/04/276/003 (5 mg, 49 × 1 tablets)
EU/1/04/276/004 (5 mg, 56 × 1 tablets)
EU/1/04/276/005 (5 mg, 98 × 1 tablets)
ABILIFY 10 mg tablets:
EU/1/04/276/006 (10 mg, 14 × 1 tablets)
EU/1/04/276/007 (10 mg, 28 × 1 tablets)
EU/1/04/276/008 (10 mg, 49 × 1 tablets)
EU/1/04/276/009 (10 mg, 56 × 1 tablets)
EU/1/04/276/010 (10 mg, 98 × 1 tablets)
ABILIFY 15 mg tablets:
EU/1/04/276/011 (15 mg, 14 × 1 tablets)
EU/1/04/276/012 (15 mg, 28 × 1 tablets)
EU/1/04/276/013 (15 mg, 49 × 1 tablets)
EU/1/04/276/014 (15 mg, 56 × 1 tablets)
EU/1/04/276/015 (15 mg, 98 × 1 tablets)
ABILIFY 30 mg tablets:
EU/1/04/276/016 (30 mg, 14 × 1 tablets)
EU/1/04/276/017 (30 mg, 28 × 1 tablets)
EU/1/04/276/018 (30 mg, 49 × 1 tablets)
EU/1/04/276/019 (30 mg, 56 × 1 tablets)
EU/1/04/276/020 (30 mg, 98 × 1 tablets)
Date of first authorisation: 04 June 2004
Date of latest renewal: 04 June 2009