Senshio Shionogi B.V. · Authorised · authorised 14 Jan 2015 · ATC G03XC05
Therapeutic indication (EMA)
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
Active substance
Ospemifene
- US FDA 2
- EMA 1
- Health Canada 1
- US price lines 1
- NHS prices 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| OSPHENA | 60MG | tablet · oral | DUCHESNAY | Prescription | 26 Feb 2013 |
| OSPEMIFENE | 60MG | tablet · oral | HETERO LABS LTD V | Discontinued | 13 Feb 2024 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| OSPHENA | 02518112 | 60 MG | TABLET · ORAL | DUCHESNAY INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | OSPHENA 60 MG TABLET | $8.17284 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Ospemifene 60mg tablets | £39.50 | 28 tablet | 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.
Safety signals and safety-related labeling changes
- US FDA 7 Feb 2025 OSPHENA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.