Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-8096 |
| Trade Name | Dose Form | Strength | Identifier |
| Abbapram | Film coated 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 | 18/3/2008 | Approval lapsed Approval date: 2/10/2008 Notification date: 23/9/2011 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Citalopram hydrobromide 24.98mg equivalent to 20 mg citalopram | H Lundbeck A/S Oddenvej 182 Lumsaas Nykoebing Sjaelland DK-4500 DENMARK | |
| Excipient | ||
| Croscarmellose sodium | ||
| Glycerol | ||
| Hypromellose | ||
| Lactose monohydrate | ||
| Macrogol 400 | ||
| Magnesium stearate | ||
| Maize starch | ||
| Microcrystalline cellulose | ||
| Povidone | ||
| Titanium dioxide |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Eurofins Pharma A/S Strandesplanaden 110 Vallensbaek Strand DK-2665 DENMARK |
| H Lundbeck A/S Ottiliavej 7-9 Valby DK-2500 DENMARK | |
| Patheon France SA 40 Boulevard de Champaret Bourgoin-Jallieu F-38317 FRANCE | |
| Statens Serum Institut Artillerivej 5 Copenhagen S DK-2300 DENMARK | |
| Manufacture of Final Dose Form | H Lundbeck A/S Ottiliavej 7-9 Valby DK-2500 DENMARK |
| Patheon France SA 40 Boulevard de Champaret Bourgoin-Jallieu F-38317 FRANCE | |
| Packing | Famar Italia SpA Via Zambeletti, 25 Baranzate Milano 20021 ITALY |
| Famar L'Aigle Zone Industrielle No 1 Route de Crulai L'Aigle 61300 FRANCE | |
| H Lundbeck A/S Ottiliavej 7-9 Valby DK-2500 DENMARK | |
| Patheon France SA 40 Boulevard de Champaret Bourgoin-Jallieu F-38317 FRANCE | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, 28 tablets | 28 tablets | 60 months from date of manufacture stored at or below 25°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 12/8/2011 | Self-Assessable Change Notification | Finished product specifications/test methods - Grade 1 (Self assessable) | Notified | 23/8/2011 | |
| 18/3/2008 | New Intermediate-risk Medicine Application | Additional name - Grade 2 | Granted 2/10/2008 | 18/3/2008 |
