Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-6869/1 |
| Trade Name | Dose Form | Strength | Identifier |
| Pam's Paracetamol Tablets | Tablet | 500 mg | capsule shaped |
| Sponsor | Application date | Registration situation | Classification |
| REX Medical Ltd P O Box 18119 Glen Innes AUCKLAND 1743 | 15/3/2002 | Consent given Approval date: 14/11/2002 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Paracetamol 500mg | Farmson Pharmaceutical Gujarat Pvt Ltd (Unit I), 28-35, GIDC Nandesari District Vadodara Gujarat 391340 INDIA | |
| Granules India Limited 8-3-1066, Plot No. 11 Sringar Colony Hyderabad 500 873 INDIA | ||
| SpecGx LLC 8801 Capital Boulevard Raleigh North Carolina 27616-3116 UNITED STATES OF AMERICA | ||
| Excipient | ||
| Hydrated silica | ||
| Magnesium stearate | ||
| Maize starch | ||
| Povidone | ||
| Purified talc | ||
| Sodium laurilsulfate | ||
| Sodium metabisulfite | ||
| Sodium starch glycolate |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Sharon Bio-Medicine Limited Central Hope Town Selaqui Industrial Area Dehradun Uttarakhand IN-248 001 INDIA |
| Manufacture of Final Dose Form | Cipla Ltd Manufacturing Division Plot No. A-33/1/2 Patalganga Industrial Area District Raigad, (Maharashtra) 410 220 INDIA |
| Cipla Ltd Manufacturing Division Plot No. D-7, MIDC Industrial Area Kurkumbh Village, Taluka - Daund District - Pune, Maharashtra State 413 802 INDIA | |
| Sharon Bio-Medicine Limited Central Hope Town Selaqui Industrial Area Dehradun Uttarakhand IN-248 001 INDIA | |
| Packing | Cipla Ltd Manufacturing Division Plot No. A-33/1/2 Patalganga Industrial Area District Raigad, (Maharashtra) 410 220 INDIA |
| Cipla Ltd Manufacturing Division Plot No. D-7, MIDC Industrial Area Kurkumbh Village, Taluka - Daund District - Pune, Maharashtra State 413 802 INDIA | |
| Sharon Bio-Medicine Limited Central Hope Town Selaqui Industrial Area Dehradun Uttarakhand IN-248 001 INDIA | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC/Aluminium - 20 tablets | 20 tablets | 36 months from date of manufacture stored at or below 30°C |
Indications
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 18/3/2024 | Self-Assessable Change Notification | Active ingredient specifications/test methods - G1 (Self assessable) | Notified | 25/3/2024 |
