Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-7843/3 |
Trade Name | Dose Form | Strength | Identifier |
Abilify Maintena | Injection with diluent | 300 mg | |
Sponsor | Application date | Registration situation | Classification |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 27/1/2015 | Not available Approval date: 20/8/2015 Notification date: 2/9/2015 | Prescription |
Composition
Component | Ingredient | Manufacturer |
diluent | Excipient | |
Water for injection | ||
powder for injection | Active | |
Aripiprazole monohydrate 312.05mg equivalent to aripiprazole 300 mg | Otsuka Pharmaceutical Co Ltd Second Tokushima Factory Kawauchi-cho Tokushima-shi Tokushimi 771-0182 JAPAN | |
Valdepharm Parc d'incarville - CS 10606 Val de Reuil Cedex 27106 FRANCE | ||
Excipient | ||
Carmellose sodium | ||
Mannitol | ||
Monobasic sodium phosphate monohydrate | ||
Sodium hydroxide |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Elaiapharm 2881 Routes des Cretes Z I Les Bouillides Sophia Antipolis Valbonne 06560 FRANCE |
Eurofins Biopharma Product Testing Denmark A/S Ornebjergvej 1 Glostrup 2600 DENMARK | |
Eurofins Biopharma Product Testing Ireland Limited Ida Industrial Estate Clogherane Dungarvan X35 T628 IRELAND | |
H Lundbeck A/S Ottiliavej 7-9 Valby DK-2500 DENMARK | |
Particle Analytical ApS Agern Alle 3 Horsholm DENMARK | |
Siegfried Hameln GmbH Langes Feld 13 Hameln 31789 GERMANY | |
Manufacture of Diluent | Elaiapharm 2881 Routes des Cretes Z I Les Bouillides Sophia Antipolis Valbonne 06560 FRANCE |
Siegfried Hameln GmbH Langes Feld 13 Hameln 31789 GERMANY | |
Manufacture of Final Dose Form | Otsuka Pharmaceutical Co Ltd 306-2 Otsubo Koniu Naka-cho Naka-gun Tokushima JAPAN |
Otsuka Pharmaceutical CoLtd Tokushima Mima Factory 1-3 Azasatohirano Mima-cho Mima-shi Tokushima 771-2106 JAPAN | |
Packing | Elaiapharm 2881 Routes des Cretes Z I Les Bouillides Sophia Antipolis Valbonne 06560 FRANCE |
Otsuka Pharmaceutical Co Ltd 306-2 Otsubo Koniu Naka-cho Naka-gun Tokushima JAPAN | |
Otsuka Pharmaceutical CoLtd Tokushima Mima Factory 1-3 Azasatohirano Mima-cho Mima-shi Tokushima 771-2106 JAPAN | |
Siegfried Hameln GmbH Langes Feld 13 Hameln 31789 GERMANY | |
Secondary Packaging | Elaiapharm 2881 Routes des Cretes Z I Les Bouillides Sophia Antipolis Valbonne 06560 FRANCE |
H Lundbeck A/S Ottiliavej 7-9 Valby DK-2500 DENMARK | |
NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
Package | Contents | Shelf Life |
Combination pack, (powder + diluent) | 1 dose units | 36 months from date of manufacture stored at or below 30°C. Do not freeze. 4 hours reconstituted stored at or below 25°C |
Vial, glass, single dose, Type 1 with FluroTec(R) Plus laminated bromobutyl rubber stopper - diluent | 2 mL | 48 months from date of manufacture stored at or below 30°C. Do not freeze. |
Vial, glass, single dose, Type 1 with teflon laminated chlorobutyl rubber stopper - powder for suspension | 300 mg | 36 months from date of manufacture stored at or below 30°C. Do not freeze. |
Indications
For maintenance of clinical improvement in the treatment of schizophrenia
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
7/7/2023 | Changed Medicine Notification | Active ingredient manufacture - G4; Administrative fee (CMN) | Granted 11/9/2023 | 13/7/2023 | |
27/1/2015 | New Higher-risk Medicine Application | Abridged new higher-risk medicine not containing a new active substance | Granted 20/8/2015 | 3/2/2015 |