Revised: 26 August 2026
Medicines
Medsafe Product Detail |
||
|---|---|---|
| File ref: TT50-8285 |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Elevit with Iodine | Film coated tablet | . | |
| Sponsor | Application date | Regulatory status | Classification |
| Bayer New Zealand Limited P O Box 2825 Shortland Street Auckland 1140 |
24/12/2008 | Approval lapsed Approval date:13/05/2010 Notification date: 8/11/2024 |
Pharmacy only |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| film coated tablet | Active | |
| Biotin 0.2mg (Plus 10% stability overage) | DSM Nutritional Products France 1 Boulevard D'Alsace Village-Neuf F-68128 FRANCE | |
| Calcium ascorbate dihydrate 133mg (Eq. to 100 mg ascorbic acid + 10% stability & 5% manufacturing overage; 12.50 mg calcium) | DSM Nutritional Products Inc 206 Macks Island Drive Belvidere New Jersey 07823-1113 UNITED STATES OF AMERICA | |
| Calcium hydrogen phosphate 378.89mg (Eq. to 111.02 mg calcium) | Chemische Fabrik Budenheim Rheinstrasse 27 Budenheim D-55257 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Calcium pantothenate 10mg (Plus 5% stability & 5% manufacturing overage; eq. to 0.88 mg calcium) | DSM Nutritional Products (UK) Ltd Drakemyre, Dalry Ayrshire Scotland KA24 5JJ UNITED KINGDOM | |
| Colecalciferol 12.5ug (Plus 20% stability overage in the form of Cholecalciferol concentrate) | DSM Nutritional Products France 1 Boulevard D'Alsace Village-Neuf F-68128 FRANCE | |
| Copper sulfate 2.51mg (Plus 9% manufacturing overage; eq. to 1 mg copper) | Celtic Chemicals Ltd Unit 25 Kenfig Industrial Estate Margam Port Talbot SA13 2PE UNITED KINGDOM | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | ||
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Cyanocobalamin 4ug (Eq. to 0.004 mg Vitamin B12 (as 0.1% soln.) + 20% stability overage) | Sanofi Winthrop Industrie Rue de Verdun Saint Aubin Les Elbeuf F-76410 FRANCE | |
| D-alpha-Tocopheryl acetate 15mg (Plus 10% stability overage) | DSM Nutritional Products AG Hauptstrasse 4 Sisseln, Aargau CH-4334 SWITZERLAND | |
| Dibasic Magnesium phosphate trihydrate 217.95mg (Controlled to Germ. Ph.) | Chemische Fabrik Budenheim Rheinstrasse 27 Budenheim D-55257 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Ferrous fumarate 183mg (Eq. to 60 mg iron) | Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Folic acid 800ug (plus 15% stability & 5% manufacturing overage) | DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | |
| Light magnesium oxide 114.42mg | Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Manganese sulfate monohydrate 3.08mg (Eq. to 1 mg manganese; + 5% manufacturing overage) | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Nicotinamide 19mg (Plus 5% stability overage) | Lonza Guangzhou Ltd 39 Jinhui Road Haizhu District Guangzhou 510288 CHINA | |
| Lonza Guangzhou Pharmaceutical Ltd 68, Huangge Dadaobei Nansha District Guangzhou, Guangdong Province 511 455 CHINA | ||
| Potassium iodide 0.327mg (Eq. to 0.250 mg iodine) | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Pyridoxine hydrochloride 2.6mg (As 8.58 mg of 33% mixture + 10 % stability overage) | DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| Riboflavin 1.8mg (Plus 10% stability & 9% manufacturing overage) | DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| Thiamine nitrate 1.71mg (Eq. to 1.6 mg thiamine hydrochloride + 10% stability overage) | DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| Zinc sulfate monohydrate 20.6mg (Eq. to 7.5 mg zinc) | Grillo Werke AG Welseler Strasse 1 D-47169 Duisburg GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Excipient | ||
| Crospovidone As K30 | ||
| Ethylcellulose | ||
| Ethylcellulose | ||
| Gelatin | ||
| Glyceryl distearate | ||
| Hypromellose | ||
| Iron oxide yellow | ||
| Lactose monohydrate | ||
| Macrogol 400 | ||
| Macrogol 6000 | ||
| Magnesium stearate | ||
| Mannitol | ||
| Methylated spirits | ||
| Microcrystalline cellulose | ||
| Povidone As K-90 | ||
| Purified talc | ||
| Purified water | ||
| Purified water | ||
| Sodium starch glycolate | ||
| Titanium dioxide |
Production
| Manufacturing step | Manufacturer |
|---|---|
| Finished Product Testing | Labor LS SE & Co.KG Mangelsfeld 4 Bad Bocklet Großenbrach 97708 GERMANY |
| Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 GERMANY | |
| Synlab Analytics & Services Germany GmbH Hauptstrasse 105 Markkleeberg 04416 GERMANY | |
| Manufacture of Active Ingredient | Celtic Chemicals Ltd Unit 25 Kenfig Industrial Estate Margam Port Talbot SA13 2PE UNITED KINGDOM |
| Chemische Fabrik Budenheim Rheinstrasse 27 Budenheim D-55257 GERMANY | |
| Chemische Fabrik Budenheim Rheinstrasse 27 Budenheim D-55257 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| DSM Nutritional Products (UK) Ltd Drakemyre, Dalry Ayrshire Scotland KA24 5JJ UNITED KINGDOM | |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln, Aargau CH-4334 SWITZERLAND | |
| DSM Nutritional Products France 1 Boulevard D'Alsace Village-Neuf F-68128 FRANCE | |
| DSM Nutritional Products France 1 Boulevard D'Alsace Village-Neuf F-68128 FRANCE | |
| DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| DSM Nutritional Products Inc 206 Macks Island Drive Belvidere New Jersey 07823-1113 UNITED STATES OF AMERICA | |
| Grillo Werke AG Welseler Strasse 1 D-47169 Duisburg GERMANY | |
| Lonza Guangzhou Ltd 39 Jinhui Road Haizhu District Guangzhou 510288 CHINA | |
| Lonza Guangzhou Pharmaceutical Ltd 68, Huangge Dadaobei Nansha District Guangzhou, Guangdong Province 511 455 CHINA | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Sanofi Winthrop Industrie Rue de Verdun Saint Aubin Les Elbeuf F-76410 FRANCE | |
| Manufacture of Final Dose Form | Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 GERMANY |
| Manufacture of Intermediate Product | DSM Nutritional Products AG Hauptstrasse 4 Sisseln, Aargau CH-4334 SWITZERLAND |
| DSM Nutritional Products Inc 206 Macks Island Drive Belvidere New Jersey 07823-1113 UNITED STATES OF AMERICA | |
| Packing | Rottendorf Pharma GmbH Am Fleigendahl 3 Ennigerloh 59320 GERMANY |
| Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 Ennigerloh 59320 GERMANY | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Blister pack, PVC/PE/PVDC/Aluminium | 5 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/PE/PVDC/Aluminium | 30 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/PE/PVDC/Aluminium | 100 tablets | 36 months from date of manufacture stored at or below 25°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 24/12/2008 | New Lower-risk Medicine Application | New lower-risk medicine | Granted | 24/12/2008 | |
| 10/09/2020 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 2 | Granted | 16/09/2020 |
