Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
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 |
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Prolonged-release suspension for injection in pre-filled syringe. The suspension is white to off-white. The suspension is pH neutral (approximately 7.0). |
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 |
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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 |
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.
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
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
| 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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