ABILIFY MAINTENA 720 mg / 960 mg Prolonged-release suspension for injection Ref.[116141] Active ingredients: Aripiprazole

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Product name and form

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe.

Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe.

Pharmaceutical Form

Prolonged-release suspension for injection in pre-filled syringe.

The suspension is white to off-white. The suspension is pH neutral (approximately 7.0).

Qualitative and quantitative composition

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe:

Each pre-filled syringe contains 720 mg aripiprazole per 2.4 mL (300 mg/mL).

Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe:

Each pre-filled syringe contains 960 mg aripiprazole per 3.2 mL (300 mg/mL).

For the full list of excipients, see section 6.1.

Active Ingredient

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

Carmellose sodium
Macrogol
Povidone (E1201)
Sodium chloride
Sodium dihydrogen phosphate monohydrate (E339)
Sodium hydroxide (for pH adjustment) (E524)
Water for injections

Pack sizes and marketing

Pre-filled syringe (cyclic-olefin-copolymer) with bromobutyl plunger stopper and bromobutyl tip-cap and polypropylene plunger rod and finger grip.

Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe:

Each 960 mg pack contains one pre-filled syringe, and two sterile safety needles: one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe:

Each 720 mg pack contains one pre-filled syringe, and two sterile safety needles: one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Marketing authorization holder

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

Marketing authorization dates and numbers

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe:

EU/1/13/882/009

Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe:

EU/1/13/882/010

Date of first authorisation: 25 March 2024

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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