Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-8816b |
| Trade Name | Dose Form | Strength | Identifier |
| Silagra | Film coated tablet | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Teva Pharma (New Zealand) Limited P O Box 128 244 Remuera Auckland 1541 | 29/4/2011 | Not available Approval date: 21/7/2011 Notification date: 14/5/2018 | Prescription |
| Reference product: Viagra Film coated tablet 25 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Sildenafil citrate 140.48mg equivalent to sildenafil 100 mg | Cadila Pharmaceuticals Ltd 294 G I D C Industrial Estate Ankleshwar Gujarat 393 002 INDIA | |
| Excipient | ||
| Calcium hydrogen phosphate | ||
| Croscarmellose sodium | ||
| Hypromellose E-5 | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opadry blue 31K80865 |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| Manufacture of Final Dose Form | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| Packing | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| NZ Site of Product Release | Teva Pharma (New Zealand) Limited Level 14, 41 Shortland Street Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC-Alu | 4 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC-Alu | 12 tablets | 36 months from date of manufacture stored at or below 25°C |
Indications
Treatment of erectile dysfunction in adult males
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 10/4/2017 | Self-Assessable Change Notification | Sponsor (Self assessable) | Notified | 26/4/2017 | |
| 29/4/2011 | New Intermediate-risk Medicine Application | Abridged new intermediate-risk prescription medicine | Granted 21/7/2011 | 5/5/2011 |
