Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-7843d
Trade NameDose FormStrengthIdentifier
AbilifyTablet20 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
18/8/2006Consent given
Approval date: 1/2/2007
Prescription
 

Composition

ComponentIngredientManufacturer
tabletActive 
 Aripiprazole 20 mgOtsuka 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
 Lactose monohydrate
 Magnesium stearate
 Maize starch
 Microcrystalline cellulose

Production

Manufacturing stepManufacturer
Finished Product TestingElaiapharm
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 FormOtsuka 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
PackingElaiapharm
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 ReleaseNo site specified

Packaging

PackageContentsShelf Life
Blister pack, AL/Al 5 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al7 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 10 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 14 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 20 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 28 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al30 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 56 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 60 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 90 tablets3 years from date of manufacture stored at or below 30°C
Blister pack, AL/Al 98 tablets3 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 DateApplication TypeChange(s)StatusPayment DatePriority
24/1/2019Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable); Data sheet - reformatting only (Self assessable)Notified8/2/2019 
18/8/2006New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substances; Additional strength - Grade 1Granted 1/2/200721/8/2006 
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