Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-7843c |
| Trade Name | Dose Form | Strength | Identifier |
| Abilify | Tablet | 15 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 18/8/2006 | Consent given Approval date: 1/2/2007 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Aripiprazole 15mg | Otsuka Pharmaceutical Co Ltd Saga Factory 5006-5 Aza Higashiyama, Omagari Yoshinogari-cho, Kanzaki-Gun Saga 842-0197 JAPAN | |
| Otsuka Pharmaceutical Co Ltd Second Tokushima Factory 224-18 Hirashi Ebisuno Kawauchi-cho, Tokushima-Shi Tokushima 771-0182 JAPAN | ||
| Excipient | ||
| Hyprolose | ||
| Iron oxide yellow | ||
| Lactose monohydrate | ||
| Magnesium stearate | ||
| Maize starch | ||
| Microcrystalline cellulose |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Elaiapharm 2881 Routes des Cretes Z I Les Bouillides Sophia Antipolis Valbonne 06560 FRANCE |
| Otsuka Pharmaceutical Co Ltd Second Tokushima Factory Kawauchi-cho Tokushima-shi Tokushimi 771-0182 JAPAN | |
| Otsuka Pharmaceutical Co Ltd Tokushima Itano Factory 13 Minami Shishitoki Matsutani, Itano-cho Itano-gun, Tokushima 779-0195 JAPAN | |
| Otsuka Pharmaceutical SA Carrer de Padilla 268 Barcelona 08025 SPAIN | |
| Manufacture of Final Dose Form | Otsuka Pharmaceutical Co Ltd Second Tokushima Factory Kawauchi-cho Tokushima-shi Tokushimi 771-0182 JAPAN |
| Otsuka Pharmaceutical Co Ltd Tokushima Itano Factory 13 Minami Shishitoki Matsutani, Itano-cho Itano-gun, Tokushima 779-0195 JAPAN | |
| Packing | Elaiapharm 2881 Routes des Cretes Z I Les Bouillides Sophia Antipolis Valbonne 06560 FRANCE |
| Otsuka Pharmaceutical Co Ltd Second Tokushima Factory Kawauchi-cho Tokushima-shi Tokushimi 771-0182 JAPAN | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, Al/Al | 5 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 7 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 10 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 14 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 20 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 28 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 30 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 56 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 60 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 90 tablets | 3 years from date of manufacture stored at or below 30°C |
| Blister pack, Al/Al | 98 tablets | 3 years from date of manufacture stored at or below 30°C |
Indications
ABILIFY is indicated of the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.
ABILIFY monotherapy is indicated for acute and maintenance treatment of manic and mixed episodes with Bipolar I Disorder with or without psychotic features.
ABILIFY is indicated as an adjunctive therapy to either lithium or valporate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 17/2/2022 | Self-Assessable Change Notification | Data sheet - miscellaneous changes (Self assessable) | Notified | 2/3/2022 | |
| 18/8/2006 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances; Additional strength - Grade 1 | Granted 1/2/2007 | 21/8/2006 |
