Intrarosa Endoceutics S.A. · Authorised · authorised 8 Jan 2018 · ATC G03XX01
Therapeutic indication (EMA)
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Active substance
Prasterone
- SFDA 1
- US FDA 1
- EMA 1
- Health Canada 1
- US price lines 1
- NHS prices 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| INTRAROSA | 6.5 mg | Pessary · Vaginal use | 28 Blister | SAR 76.80 | NCE · Prescription | MUNDIPHARMA MEDICAL COMPANY | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| INTRAROSA | 6.5MG | insert · vaginal | MILLICENT | Prescription | 16 Nov 2016 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| INTRAROSA | 02493500 | 6.5 MG | OVULE · VAGINAL | COSETTE PHARMACEUTICALS, INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | INTRAROSA 6.5 MG VAG INSERT | $10.98244 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Prasterone 6.5mg pessaries | £15.94 | 28 pessary | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.