Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-7843/1a
Trade NameDose FormStrengthIdentifier
Abilify ODTOrodispersible tablet15 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 15 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
 Crospovidone
 Iron oxide yellow
 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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