Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-4913/1 |
| Trade Name | Dose Form | Strength | Identifier |
| Zithromax | Capsule | 250 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Pfizer New Zealand Limited P O Box 3998 AUCKLAND 1140 | 14/12/1990 | Approval lapsed Approval date: 16/12/1993 Notification date: 3/1/2001 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| capsule | Active | |
| Azithromycin dihydrate 250mg | Pfizer Pharmaceuticals LLC Road #2, Km 58.2 Barceloneta 00617 Puerto Rico | |
| Pfizer Inc Global Manufacturing Division Eastern Point Road Groton Connecticut 06340 United States of America | ||
| Pfizer Ireland Pharmaceuticals Ringaskiddy API Plant PO Box 140 Ringaskiddy Co. Cork Ireland |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | Pfizer Italia SrL Strada Statale No 156 Km 47600 Borgo San Michele Latina I-04010 Italy |
| Packing | Pfizer Italia SrL Strada Statale No 156 Km 47600 Borgo San Michele Latina I-04010 Italy |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, 4, 6 capsules | 24 months from date of manufacture stored at or below 30°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/1/2011 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 1; Active ingredient specifications/test methods - Grade 4; Administrative fee (CMN) | Granted 3/2/2011 | 28/1/2011 |
