Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-8390 |
| Trade Name | Dose Form | Strength | Identifier |
| Vedafil | Film coated tablet | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Viatris Limited P O Box 11183 Ellerslie AUCKLAND 1542 | 14/7/2009 | Consent given Approval date: 23/9/2010 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Sildenafil citrate 140.483mg equivalent to Sildenafil 100 mg | Mylan Laboratories Limited Unit 9 Plot No.5, Road Number 12, J.N Pharma City Parawada Mandal, Anakapalli District Tadi Village, Andhra Pradesh 531 019 INDIA | |
| Mylan Laboratories Limited Unit 8, Getula Chodavaram Poosapatirega Mandal Vizianagaram District Andhra Pradesh 535 204 INDIA | ||
| Excipient | ||
| Calcium hydrogen phosphate | ||
| Croscarmellose sodium | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opadry blue 03K80846 | ||
| Purified water | ||
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Mylan Laboratories Limited F4/F12 Malegaon MIDC Sinnar Nashik Maharashtra State 422 113 INDIA |
| Manufacture of Final Dose Form | Mylan Laboratories Limited F4/F12 Malegaon MIDC Sinnar Nashik Maharashtra State 422 113 INDIA |
| Packing | Mylan Laboratories Limited F4/F12 Malegaon MIDC Sinnar Nashik Maharashtra State 422 113 INDIA |
| Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 | |
| NZ Site of Product Release | Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer | 1 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer | 4 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer | 8 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, Clear PVC/hard tempered aluminium foil film coated with heat sealed lacquer | 12 tablets | 36 months from date of manufacture stored at or below 25°C |
Indications
VEDAFIL is indicated for the treatment of erectile dysfunction in males
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 23/2/2024 | Changed Medicine Notification | Active ingredient specifications/test methods - G2; Administrative fee (CMN); Finished product specifications/test methods - G2 | Granted 8/4/2024 | 28/2/2024 | |
| 12/1/2024 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 19/1/2024 | |
| 14/7/2009 | New Intermediate-risk Medicine Application | New intermediate-risk prescription medicine; Additional strength - Grade 1 | Granted 23/9/2010 | 28/7/2009 |
