Uses
INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Source: US FDA prescribing information
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Prasterone is a prescription medicine indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. It is available as vaginal inserts. MedsAcross supplies Prasterone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- ATC classification
- A14AA07 Prasterone · Anabolic steroid, subgroup A14AAG03XX01 Prasterone · Enclomifene, subgroup G03XX
- US FDA first approval
- 16 November 2016
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Vaginal
- Dosage forms
- Vaginal insert
- Identifiers
- UNII 459AG36T1BQ55630367
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established.
Source: US FDA prescribing information
Dosing overview
Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime.
Source: US FDA prescribing information
Contraindications
Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding.
Source: US FDA prescribing information
Warnings and precautions
Current or Past History of Breast Cancer. Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
Source: US FDA prescribing information
Side effects
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear.
Source: US FDA prescribing information
Storage
Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Prasterone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Intrarosa 6.5 mg vaginal insertVaginal Cold chain | Millicent | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Prasterone available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Prasterone and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Prasterone have?
The catalogue lists 1 brand names for Prasterone, including Intrarosa.
Is Prasterone approved by the US FDA?
Yes. The US FDA first approved Prasterone on 16 November 2016, according to Drugs@FDA.
Is Prasterone authorised in the European Union?
Yes. Prasterone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Prasterone need cold chain shipping?
At least one listed presentation of Prasterone must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Prasterone in?
Prasterone is classified under ATC code A14AA07 (Prasterone).
References
- Intrarosa prescribing information (Millicent). U.S. National Library of Medicine, DailyMed. Retrieved 17 July 2026
- Intrarosa: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 November 2026
Request Prasterone for export supply
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