Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-7843/3
Trade NameDose FormStrengthIdentifier
Abilify MaintenaInjection with diluent300 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
27/1/2015Not available
Approval date: 20/8/2015
Notification date: 2/9/2015
Prescription
 

Composition

ComponentIngredientManufacturer
diluentExcipient 
 Water for injection
powder for injectionActive 
 Aripiprazole monohydrate 312.05 mg (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 stepManufacturer
Finished Product TestingEurofins Biopharma Product Testing Denmark A/S
Ornebjergvej 1
Glostrup 2600
Denmark
 Eurofins Biopharma Product Testing Ireland Limited
Clogherane
Dungarvan
County Waterford X35 T628
Ireland
 H Lundbeck A/S
Ottiliavej 7-9
Valby DK-2500
Denmark
 Hameln Pharmaceuticals GmbH
Langes Feld 13
Hameln 31789
Germany
 Otsuka Pharmaceutical Co Ltd
306-2 Otsubo
Koniu Naka-cho
Naka-gun
Tokushima
Japan
 Particle Analytical ApS
Agern Alle 3
Horsholm
Denmark
Manufacture of DiluentHameln Pharmaceuticals GmbH
Langes Feld 13
Hameln 31789
Germany
Manufacture of Final Dose FormOtsuka Pharmaceutical Co Ltd
306-2 Otsubo
Koniu Naka-cho
Naka-gun
Tokushima
Japan
PackingHameln Pharmaceuticals GmbH
Langes Feld 13
Hameln 31789
Germany
 Otsuka Pharmaceutical Co Ltd
306-2 Otsubo
Koniu Naka-cho
Naka-gun
Tokushima
Japan
Secondary PackagingElaiapharm
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 ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Combination pack, (powder + diluent)1 dose units36 months from date of manufacture stored at or below 30°C. Do not freeze.
4 hours reconstituted stored at or below 30°C
Vial, glass, single dose, Type 1 with FluroTec(R) Plus laminated bromobutyl rubber stopper - diluent2 mL48 months from date of manufacture stored at or below 30°C
Vial, glass, single dose, Type 1 with teflon laminated chlorobutyl rubber stopper - powder for suspension300 mg36 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 DateApplication TypeChange(s)StatusPayment DatePriority
8/1/2018Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified17/1/2018 
27/1/2015New Higher-risk Medicine ApplicationAbridged new higher-risk medicine not containing a new active substanceGranted 20/8/20153/2/2015 
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