Revised: 26 August 2026
Medicines
Medsafe Product Detail |
  | |
|---|---|---|
| File ref: TT50-4050 |
| Trade Name | Dose Form | Strength | Identifier |
|---|---|---|---|
| Ovestin | Vaginal cream | 0.1 % | |
| Sponsor | Application date | Regulatory status | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 |
18/12/1986 | Consent given Approval date:18/12/1986 |
Prescription |
Composition
| Component | Ingredient | Manufacturer |
|---|---|---|
| vaginal cream | Active | |
| Estriol 0.1%{relative} | Aspen Oss B.V Kloosterstraat 6 Oss 5349 AB NETHERLANDS | |
| Aspen Oss B.V Veersemeer 4 Oss 5347 JN NETHERLANDS | ||
| Excipient | ||
| Cetyl alcohol | ||
| Chlorhexidine hydrochloride | ||
| Glycerol | ||
| Lactic acid | ||
| Octyldodecanol | ||
| Polysorbate 60 | ||
| Purified water | ||
| Sodium hydroxide | ||
| Sorbitan stearate | ||
| Spermaceti | ||
| Stearyl alcohol |
Production
| Manufacturing step | Manufacturer |
|---|---|
| Finished Product Testing | Aspen Bad Oldesloe GmbH 32-36 Industriestrasse Bad Oldesloe D-23843 GERMANY |
| Manufacture of Active Ingredient | Aspen Oss B.V Kloosterstraat 6 Oss 5349 AB NETHERLANDS |
| Aspen Oss B.V Veersemeer 4 Oss 5347 JN NETHERLANDS | |
| Manufacture of Final Dose Form | Aspen Bad Oldesloe GmbH 32-36 Industriestrasse Bad Oldesloe D-23843 GERMANY |
| Organon (Ireland) Ltd Drynam Road Swords County Dublin IRELAND | |
| Packing | Aspen Bad Oldesloe GmbH 32-36 Industriestrasse Bad Oldesloe D-23843 GERMANY |
| Organon (Ireland) Ltd Drynam Road Swords County Dublin IRELAND | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf life |
|---|---|---|
| Tube, 15g | 15 g | 36 months from date of manufacture stored at or below 25°C. Do not freeze |
| Tube, Physician's sample, 15g | 15 g | 36 months from date of manufacture stored at or below 25°C. Do not freeze |
Indications
Atrophy of the lower urogenital tract related to oestrogen deficiency, notably:
· for the treatment of vaginal complaints such as dyspareunia, dryness and itching.
· for the prevention of recurrent infections of the vagina and lower urinary tract.
· in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence.
Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery.
A diagnostic aid in case of a doubtful atrophic cervical smear.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
|---|---|---|---|---|---|
| 12/11/2025 | Changed Medicine Notification | Finished product specifications/test methods - G3 | Withdrawn | 24/11/2025 |
