Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-8198 |
| Trade Name | Dose Form | Strength | Identifier |
| Utrogestan | Capsule | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmaco (NZ) Ltd P O Box 4079 AUCKLAND 1140 | 20/8/2008 | Consent given Approval date: 23/3/2017 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| capsule, To 2 April 2013 | Active | |
| Progesterone 100mg | Symbiotec Pharmalab Private Limited Plot No 5,6,7 & 8, Special Economic Zone Phase II, Pharma Zone, District Dhar Pithampur, Madhya Pradesh 454 774 INDIA | |
| Jiangsu Jiaerke Pharmaceuticals Group Corp Ltd Changzhou City Zhenglu Jiangsu Province 213111 CHINA | ||
| Excipient | ||
| Arachis oil | ||
| Gelatin | ||
| Glycerol | ||
| Soya oil | ||
| Titanium dioxide | ||
| capsule, From 31 October 2022 at site Olic (Thailand) Limited | Active | |
| Progesterone 100mg | ||
| Excipient | ||
| Gelatin | ||
| Glycerol | ||
| Purified water | ||
| Soya oil | ||
| Sunflower oil | ||
| Titanium dioxide | ||
| capsule, From 2 April 2013 to 31 October 2022 | Active | |
| Progesterone 100mg | ||
| Excipient | ||
| Gelatin | ||
| Glycerol | ||
| Purified water | ||
| Soya oil | ||
| Sunflower oil | ||
| Titanium dioxide | ||
| capsule, From 31 October 2022 at site Cyndea Pharma S.L. | Active | |
| Progesterone 100mg | ||
| Excipient | ||
| Gelatin | ||
| Glycerol | ||
| Purified water | ||
| Soya oil | ||
| Sunflower oil | ||
| Titanium dioxide |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Cyndea Pharma S.L. Poligono Industrial Emiliano Revilla Sanz. Avenida de Agreda, 31, Olvega Soria 42110 SPAIN |
| NextPharma Ploermel Zone Industrielle de Camagnon Ploermel 56800 FRANCE | |
| Olic (Thailand) Limited Bangpa-In Industrial Estate 166 Moo 16, Udomsorayuth Road, Bankrasan Sub-District, Ayutthaya Prov. 13160 THAILAND | |
| Manufacture of Final Dose Form | Cyndea Pharma S.L. Poligono Industrial Emiliano Revilla Sanz. Avenida de Agreda, 31, Olvega Soria 42110 SPAIN |
| NextPharma Ploermel Zone Industrielle de Camagnon Ploermel 56800 FRANCE | |
| Olic (Thailand) Limited Bangpa-In Industrial Estate 166 Moo 16, Udomsorayuth Road, Bankrasan Sub-District, Ayutthaya Prov. 13160 THAILAND | |
| Packing | Cyndea Pharma S.L. Poligono Industrial Emiliano Revilla Sanz. Avenida de Agreda, 31, Olvega Soria 42110 SPAIN |
| Olic (Thailand) Limited Bangpa-In Industrial Estate 166 Moo 16, Udomsorayuth Road, Bankrasan Sub-District, Ayutthaya Prov. 13160 THAILAND | |
| Secondary Packaging | Pharmaco (NZ) Ltd Level 1 4 Fisher Crescent Mt Wellington AUCKLAND 1060 |
| NZ Site of Product Release | Pharmaco (NZ) Ltd 4 Fisher Crescent Mt Wellington AUCKLAND 1060 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC/Aluminium or PVC/PVdC/Aluminium | 15 capsules | 36 months from date of manufacture stored at or below 30°C. Do not refrigerate. |
| Blister pack, PVC/Aluminium or PVC/PVdC/Aluminium | 30 capsules | 36 months from date of manufacture stored at or below 30°C. Do not refrigerate. |
Indications
Adjunctive use with an oestrogen in postmenopausal women with an intact uterus (for hormone replacement therapy [HRT]).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/9/2023 | Changed Medicine Notification | Labelling - G2 | Granted 27/10/2023 | 28/9/2023 | |
| 16/2/2015 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance; Additional strength - Grade 1 | Granted 23/3/2017 | 20/2/2015 | |
| 20/8/2008 | Provisional Consent (Section 23) | New medicine - provisional consent | Granted 2/4/2009 | 20/8/2008 |
