Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-6713 |
| Trade Name | Dose Form | Strength | Identifier |
| Gees Linctus | Linctus | . | |
| Sponsor | Application date | Registration situation | Classification |
| PSM Healthcare Ltd trading as API Consumer Brands P O Box 76401 Manukau City AUCKLAND 2241 | 5/3/2001 | Approval lapsed Approval date: 14/6/2001 Notification date: 18/3/2022 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| linctus | Active | |
| Opium tincture 1.369%{relative} ((=1.608%w/v) = 0.0165%w/v anhydrous morphine) | Temad Company, Active Pharmaceutical Ingredients 28Km, Karaj Makhsous Road Tehran IRAN (ISLAMIC REPUBLIC OF) | |
| Macfarlan Smith Ltd 10 Wheatfield Road Edinburgh Scotland EH11 2QA UNITED KINGDOM | ||
| Squill oxymel 3.78%{relative} (as SFM Oxymel Squill 125:1000 = 1.67%w/v squill) | Ransom Naturals Limited 53 Burymead Road Hitchin Hertfordshire SG5 1RT UNITED KINGDOM | |
| Excipient | ||
| Benzoic acid | ||
| Camphor | ||
| Ethanol | ||
| Honey | ||
| Methyl hydroxybenzoate | ||
| Purified water | ||
| Star anise oil | ||
| Sugar premium liquid | ||
| Tolu syrup |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | PSM Healthcare Ltd trading as API Consumer Brands 172 Plunket Avenue Manukau AUCKLAND 2104 |
| Packing | PSM Healthcare Ltd trading as API Consumer Brands 172 Plunket Avenue Manukau AUCKLAND 2104 |
| Secondary Packaging | DHL Supply Chain (New Zealand) Ltd 30 Airpark Drive Mangere Auckland 2022 |
| NZ Site of Product Release | PSM Healthcare Ltd trading as API Consumer Brands 172 Plunket Avenue Manukau AUCKLAND 2104 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, glass, amber, CRC cap | 200 mL | 24 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, HDPE | 2 L | 24 months from date of manufacture stored at or below 25°C |
Indications
Relief from wet, productive and irritating cough (label claim).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 29/7/2020 | Changed Medicine Notification | Finished product packing site - Grade 1; Administrative fee (CMN) | Granted 2/9/2020 | 14/8/2020 |
