ABILIFY Tablet Ref.[6216] Active ingredients: Aripiprazole

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

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.

Active Ingredient 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

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

Marketing authorization dates and numbers

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

Drugs

Drug Countries
ABILIFY Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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