Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-7843/1b |
Trade Name | Dose Form | Strength | Identifier |
Abilify ODT | Orodispersible tablet | 20 mg | |
Sponsor | Application date | Registration situation | Classification |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 18/8/2006 | Approval lapsed Approval date: 26/4/2007 Notification date: 26/11/2020 | Prescription |
Composition
Component | Ingredient | Manufacturer |
orodispersible tablet | Active | |
Aripiprazole 20mg | Otsuka 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 step | Manufacturer |
Finished Product Testing | Bristol-Myers Squibb Australia Pty Ltd 556 Princes Highway Noble Park VIC 3174 AUSTRALIA |
Bristol-Myers Squibb Manufacturing Company Unlimited 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 Form | Bristol-Myers Squibb Manufacturing Company Unlimited Company State Road No 114, km 3.2 Foreign Trade Zone No 7 Mayaguez 00680 PUERTO RICO |
Packing | Bristol-Myers Squibb S.r.l. Loc. Fontana Del Ceraso Anagni FR 03012 ITALY |
NZ Site of Product Release | No site specified |
Packaging
Package | Contents | Shelf Life |
Blister pack, Al/Al x 5 tablets | 5 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 7 tablets | 7 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 10 tablets | 10 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 14 tablets | 14 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 20 tablets | 20 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 28 tablets | 28 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 30 tablets | 30 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 56 tablets | 56 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 60 tablets | 60 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 84 tablets | 84 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 90 tablets | 90 tablets | 36 months from date of manufacture stored at or below 30°C |
Blister pack, Al/Al x 98 tablets | 98 tablets | 36 months from date of manufacture stored at or below 30°C |
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
8/4/2015 | Self-Assessable Change Notification | Sponsor (Self assessable) | Notified | 15/4/2015 | |
18/8/2006 | New Higher-risk Medicine Application | zAdditional dose form - Grade 2; Additional strength - Grade 1 | Granted 26/4/2007 | 6/3/2007 |