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ABILIFY Tablet (2018)

Active ingredients: Aripiprazole

Product Name and Form

ABILIFY 5 mg tablets.
ABILIFY 10 mg tablets.
ABILIFY 15 mg tablets.
ABILIFY 30 mg tablets.

Pharmaceutical form

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.

Qualitative and Quantitative Composition

ABILIFY 5 mg tablets

Each tablet contains 5 mg of aripiprazole.

Excipient with known effect: 67 mg lactose per tablet.

ABILIFY 10 mg tablets

Each tablet contains 10 mg of aripiprazole.

Excipient with known effect: 62.18 mg lactose per tablet.

ABILIFY 15 mg tablets

Each tablet contains 15 mg of aripiprazole.

Excipient with known effect: 57 mg lactose per tablet.

ABILIFY 30 mg tablets

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.

Chemical substance
Description
Aripiprazole

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.

List of excipients

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)

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Date of first authorisation: 04 June 2004
Date of latest renewal: 04 June 2009

Marketing authorization number:

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)