Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-0415/4 |
| Trade Name | Dose Form | Strength | Identifier |
| Mylanta P | Oral suspension | . | |
| Sponsor | Application date | Registration situation | Classification |
| Johnson & Johnson (New Zealand) Limited P O Box 62-185 Sylvia Park Auckland 1644 | 11/4/2001 | Approval lapsed Approval date: 26/7/2001 Notification date: 22/7/2021 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| oral suspension | Active | |
| Aluminium hydroxide 40 mg/mL (added as (10.85% AlOH dried ) aluminium / magnesium Co-Gel C655, 9.4% overage) | SRL Pharma GmbH Giulinistrasse 2 Ludwigshafen D-67065 GERMANY | |
| Magnesium hydroxide 40 mg/mL (added as (10.85% MgOH dried ) aluminium / magnesium Co-Gel C655 9.4% overage) | SRL Pharma GmbH Giulinistrasse 2 Ludwigshafen D-67065 GERMANY | |
| Simeticone 4 mg/mL (added as 13.3 mg/mL of simethicone emulsion 30%) | Dow Silicones Corporation 1635 North Gleaner Road Hemlock Michigan 48626 UNITED STATES OF AMERICA | |
| Excipient | ||
| Acesulfame potassium | ||
| Butyl hydroxybenzoate | ||
| Enhancer flavour FADP925 (natural sweetness) | ||
| Ethanol | ||
| Ethyl hydroxybenzoate | ||
| Mint flavour SN011397 | ||
| Propyl hydroxybenzoate | ||
| Purified water | ||
| Sorbitol | ||
| Xanthan gum | ||
| Xylitol |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Ensign Laboratories Pty Limited 490-500 Wellington Road Mulgrave VIC 3170 AUSTRALIA |
| Manufacture of Final Dose Form | Ensign Laboratories Pty Limited 490-500 Wellington Road Mulgrave VIC 3170 AUSTRALIA |
| Packing | Ensign Laboratories Pty Limited 490-500 Wellington Road Mulgrave VIC 3170 AUSTRALIA |
| NZ Site of Product Release | Johnson & Johnson (New Zealand) Limited 507 Mt. Wellington Highway Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Bottle, plastic, HDPE bottles | 500 mL | 18 months from date of manufacture stored at or below 30°C 6 months opened stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
Relief from indigestion, heartburn, upset stomach, flatulence and wind pain.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 12/11/2015 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 1; Administrative fee (CMN) | Granted 27/11/2015 | 17/11/2015 |
