Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-4224/1 |
| Trade Name | Dose Form | Strength | Identifier |
| Sandrena | Transdermal gel | 0.5 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Orion Pharma (NZ) Limited c/o Max Health Ltd PO Box 44452 Auckland 1246 | 8/12/1994 | Pending Approval date: 16/4/1998 Notification date: 4/9/2007 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| transdermal gel, Formulation until 2007 when approval lapsed | Active | |
| Estradiol 1 mg/g | Valdepharm Parc d'incarville - CS 10606 Val de Reuil Cedex 27106 FRANCE | |
| Aspen Oss B.V Veersemeer 4 Oss 5347 JN NETHERLANDS | ||
| Bayer AG Ernst-Schering Strasse 14 Bergkamen 59192 GERMANY | ||
| Aspen Oss B.V Kloosterstraat 6 Oss 5349 AB NETHERLANDS | ||
| Excipient | ||
| Carbomer | ||
| Ethanol | ||
| Propylene glycol | ||
| Purified water | ||
| Sodium hydroxide | ||
| transdermal gel, Formulation from 2024 | Active | |
| Estradiol hemihydrate 0.52mg equivalent to 0.5 mg estradiol (0.1 % w/w) | ||
| Excipient | ||
| Carbomer | ||
| Ethanol as 96% ethanol | ||
| Propylene glycol | ||
| Trolamine | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Eurofins BioPharma Product Testing Czech Republic s.r.o Videnska 204/125 Brno 61900 CZECH REPUBLIC |
| Orion Corporation Orion Pharma Orionintie 1 Espoo FI-02200 FINLAND | |
| Orion Corporation Orion Pharma Tengstrominkatu 8 Turku FI-20360 FINLAND | |
| Manufacture of Final Dose Form | Orion Corporation Turku Factory Tengstrominkatu 8 Turku FI-20360 FINLAND |
| Packing | Orion Corporation Turku Factory Tengstrominkatu 8 Turku FI-20360 FINLAND |
| NZ Site of Product Release | Max Health Limited Office 6 One Link Building 2 Segar Ave, Pt Chevalier Auckland |
Packaging
| Package | Contents | Shelf Life |
| Sachet, laminate, polyethylene copolymer/aluminium/polyester, 0.5g | 28 dose units | 36 months from date of manufacture stored at or below 25°C |
| Sachet, laminate, polyethylene copolymer/aluminium/polyester, 0.5g | 91 dose units | 36 months from date of manufacture stored at or below 25°C |
Indications
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 30/10/2023 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance; Additional strength - Grade 1 | Initial evaluation | 6/12/2023 |
