Revised: 26 August 2026
Medicines
Medsafe Product Detail |
||
|---|---|---|
| File ref: TT50-6706/2 |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Elevit | Film coated tablet | Vitamin D 5 microgram | |
| Sponsor | Application date | Regulatory status | Classification |
| Bayer New Zealand Limited P O Box 2825 Shortland Street Auckland 1140 |
29/01/2020 | Consent given Approval date:25/03/2021 Notification date: 3/02/2022 |
Pharmacy only |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| film coated tablet | Active | |
| Ascorbic acid 85mg | CSPC Weisheng Pharmaceutical (Shijiazhuang) Co Ltd 898 Zhongshan East Road High-tech Industrial Development Zone RC-050 035 Shijiazhuang City, Hebei Province CHINA | |
| Biotin 0.03mg | DSM Nutritional Products France 1 Boulevard D'Alsace Village-Neuf F-68128 FRANCE | |
| Calcium hydrogen phosphate 407.67mg | Chemische Fabrik Budenheim Rheinstrasse 27 Budenheim D-55257 GERMANY | |
| Calcium pantothenate 6.52mg | DSM Nutritional Products (UK) Ltd Drakemyre, Dalry Ayrshire Scotland KA24 5JJ UNITED KINGDOM | |
| Colecalciferol 0.005mg | DSM Nutritional Products France 1 Boulevard D'Alsace Village-Neuf F-68128 FRANCE | |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | ||
| Copper sulfate 2.51mg | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Cyanocobalamin 0.0026mg | Sanofi Winthrop Industrie Rue de Verdun Saint Aubin Les Elbeuf F-76410 FRANCE | |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | ||
| DL-alpha Tocopheryl acetate 22.35mg | DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | |
| Ferrous fumarate 182.52mg | FerroPharma Chemicals Ltd 6766 Doc Erdosor HUNGARY | |
| Particle Dynamics 2629 South Hanley Road St Louis Missouri 63144 UNITED STATES OF AMERICA | ||
| Folic acid 0.8mg | DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | |
| Heavy magnesium oxide 165.25mg | Kyowa Chemical Industry Co., Ltd. 4035 Hayashida-cho Sakaide Kagawa 762-0012 JAPAN | |
| Manganese sulfate monohydrate 5.72mg | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | ||
| Nicotinamide 18mg | Lonza Guangzhou Pharmaceutical Ltd 68, Huangge Dadaobei Nansha District Guangzhou, Guangdong Province 511 455 CHINA | |
| Potassium iodide 0.288mg | Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | |
| Pyridoxine hydrochloride 2.31mg | DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| Riboflavin 1.4mg | DSM Nutritional Products GmbH Emil Barrell Strasse 3 Grenzach-Wyhlen D-79639 GERMANY | |
| Sodium selenite 0.105mg | Retorte GmbH Selenium Chemicals & Metals Sulzbacher Strasse 45 Rothenbach D-90552 GERMANY | |
| Thiamine nitrate 1.723mg | 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 | ||
| Zinc citrate trihydrate 35.24mg | Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY | |
| Excipient | ||
| Colloidal silicon dioxide | ||
| Croscarmellose sodium | ||
| Ethanol | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Povidone | ||
| Purified talc | ||
| Sepifilm gloss | ||
| Sepisperse Dry White |
Production
| Manufacturing step | Manufacturer |
|---|---|
| Finished Product Testing | PT Bayer Indonesia Jalan Raya Jakarta Bogor Km 32 Cisalak Kec. Sukmajaya, Kota Depok Jawa Barat 16416 INDONESIA |
| Manufacture of Active Ingredient | Chemische Fabrik Budenheim Rheinstrasse 27 Budenheim D-55257 GERMANY |
| CSPC Weisheng Pharmaceutical (Shijiazhuang) Co Ltd 898 Zhongshan East Road High-tech Industrial Development Zone RC-050 035 Shijiazhuang City, Hebei Province CHINA | |
| 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 CH-4334 SWITZERLAND | |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln 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 | |
| FerroPharma Chemicals Ltd 6766 Doc Erdosor HUNGARY | |
| Kyowa Chemical Industry Co., Ltd. 4035 Hayashida-cho Sakaide Kagawa 762-0012 JAPAN | |
| 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 | |
| Particle Dynamics 2629 South Hanley Road St Louis Missouri 63144 UNITED STATES OF AMERICA | |
| Retorte GmbH Selenium Chemicals & Metals Sulzbacher Strasse 45 Rothenbach D-90552 GERMANY | |
| Sanofi Winthrop Industrie Rue de Verdun Saint Aubin Les Elbeuf F-76410 FRANCE | |
| Manufacture of Final Dose Form | PT Bayer Indonesia Jalan Raya Jakarta Bogor Km 32 Cisalak Kec. Sukmajaya, Kota Depok Jawa Barat 16416 INDONESIA |
| Manufacture of Intermediate Product | Dr. Paul Lohmann GmbH & Co. KGaA Hauptstrasse 2 Emmerthal D-31860 GERMANY |
| DSM Nutritional Products AG Hauptstrasse 4 Sisseln CH-4334 SWITZERLAND | |
| DSM Nutritional Products Inc 206 Macks Island Drive Belvidere New Jersey 07823-1113 UNITED STATES OF AMERICA | |
| Particle Dynamics 2629 South Hanley Road St Louis Missouri 63144 UNITED STATES OF AMERICA | |
| Packing | PT Bayer Indonesia Jalan Raya Jakarta Bogor Km 32 Cisalak Kec. Sukmajaya, Kota Depok Jawa Barat 16416 INDONESIA |
| NZ Site of Product Release | Bayer New Zealand Limited B:Hive Building 74 Taharoto Road Takapuna Auckland 0622 |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Blister pack, PVC/Polyurethane/PVDC | 5 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/Polyurethane/PVDC | 30 tablets | 36 months from date of manufacture stored at or below 25°C |
| Blister pack, PVC/Polyurethane/PVDC | 100 tablets | 36 months from date of manufacture stored at or below 25°C |
Indications
To supplement maternal dietary intake during pregnancy and lactation
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 29/01/2020 | New Lower-risk Medicine Application | New lower-risk medicine | Granted | 4/02/2020 | |
| 30/06/2022 | Changed Medicine Notification | Active ingredient manufacturing site | Granted | 12/07/2022 |
