Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-7843/1b
Trade NameDose FormStrengthIdentifier
Abilify ODTOrodispersible tablet20 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
18/8/2006Not available
Approval date: 26/4/2007
Notification date: 19/11/2012
Prescription
 

Composition

ComponentIngredientManufacturer
orodispersible 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 
 Acesulfame potassium
 Aspartame
 Calcium silicate
 Colloidal silicon dioxide
 Croscarmellose sodium
 Magnesium stearate
 Microcrystalline cellulose
 Tartaric acid
 Vanilla flavour 27243
 Xylitol

Production

Manufacturing stepManufacturer
Finished Product TestingBristol-Myers Squibb Australia Pty Ltd
556 Princes Highway
Noble Park
VIC 3174
Australia
 Bristol-Myers Squibb Manufacturing Company
State Road No 114, km 3.2
Foreign Trade Zone No 7
Mayaguez 00680
Puerto Rico
 Bristol-Myers Squibb S.r.l.
Loc. Fontana Del Ceraso
Anagni FR 03012
Italy
Manufacture of Final Dose FormBristol-Myers Squibb Manufacturing Company
State Road No 114, km 3.2
Foreign Trade Zone No 7
Mayaguez 00680
Puerto Rico
PackingBristol-Myers Squibb S.r.l.
Loc. Fontana Del Ceraso
Anagni FR 03012
Italy
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Blister pack, Al/Al x 5 tablets5 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 7 tablets7 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 10 tablets10 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 14 tablets14 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 20 tablets20 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 28 tablets28 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 30 tablets30 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 56 tablets56 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 60 tablets60 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 84 tablets84 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 90 tablets90 tablets36 months from date of manufacture stored at or below 30°C
Blister pack, Al/Al x 98 tablets98 tablets36 months from date of manufacture stored at or below 30°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
8/4/2015Self-Assessable Change NotificationSponsor (Self assessable)Notified15/4/2015 
18/8/2006New Higher-risk Medicine ApplicationzAdditional dose form - Grade 2; Additional strength - Grade 1Granted 26/4/20076/3/2007 
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