Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-6753 |
| Trade Name | Dose Form | Strength | Identifier |
| Primidone | Tablet | 250 mg | Clinect |
| Sponsor | Application date | Registration situation | Classification |
| Clinect NZ Pty Limited c/- Ebos Group Limited 108 Wrights Road Christchurch 8024 | 31/5/2001 | Consent given Approval date: 2/8/2012 | Prescription |
| Reference product: Mysoline Tablet 250 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Primidone 250mg | Nantong Jinghua Pharmaceutical Co., Ltd. No. 20, 3 Haibin Road Yanhai Economic Development Zone Rudong, Nantong Jiangsu 226407 CHINA | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Croscarmellose sodium | ||
| Magnesium stearate | ||
| Methylcellulose |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Apotex Inc 150 Signet Drive Weston Ontario M9L 1T9 CANADA |
| Apotex Inc 380 Elgin Mills Road East Richmond Hill Ontario L4C 5H2 CANADA | |
| Apotex Inc 50 Steinway Boulevard Etobicoke Ontario M9W 6Y3 CANADA | |
| Manufacture of Final Dose Form | Apotex Inc 150 Signet Drive Weston Ontario M9L 1T9 CANADA |
| Overlabelling | DHL Supply Chain (New Zealand) Ltd 30 Airpark Drive Mangere Auckland 2022 |
| DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 | |
| Packing | Apotex Inc 4100 Weston Road Weston Ontario M9L 2Y6 CANADA |
| Apotex Inc 50 Steinway Boulevard Etobicoke Ontario M9W 6Y3 CANADA | |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE/white PP cap/Al seal | 100 tablets | 60 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, HDPE/blue PP cap/Al seal | 100 tablets | 60 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, HDPE/white PP cap/Al foil seal | 500 tablets | 60 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, HDPE/blue PP cap/Al foil seal | 500 tablets | 60 months from date of manufacture stored at or below 25°C |
Indications
Indicated for the management of grand mal epilepsy
Indicated for the management of psychomotor (temporal lobe) epilepsy
Is also of value in the management of Jacksonian seizures
Is also of value in the management of focal seizures
Is also of value in the management of myoclonic jerks
Is also of value in the management of akinetic attacks
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 8/11/2021 | Self-Assessable Change Notification | Finished product specifications/test methods - Grade 1 (Self assessable) | Notified | 16/11/2021 | |
| 6/12/2011 | New Intermediate-risk Medicine Application | New intermediate-risk prescription medicine | Granted 2/8/2012 | 16/12/2011 |
