Active substance
Tibolone
- SFDA 2
- Health Canada 1
- NHS prices 1
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LIVIAL 2.5MG TAB | 2.5 mg | Tablet · Oral use | 28 Blister | SAR 76.80 | NCE · Prescription | ORGANON | Valid |
| TiboFem | 2.5 mg | Tablet · Oral use | 28 Blister | SAR 60.30 | Generic · Prescription | Mithra Pharmaceuticals S A | Valid |
Indications — CHI Daman Drug Formulary
MENOPAUSE; MENSTRUAL DISORDERS; OSTEOPOROSIS
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| TIBELLA | 02488361 | 2.5 MG | TABLET · ORAL | BIOSYENT PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Tibolone 2.5mg tablets | £5.52 | 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
- EMA PRAC 14 May 2020 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2020 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: No - EMA PRAC 3 Oct 2019 PRAC signal: New information on the known risk of breast cancer
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Tibolone: benefit-risk balance
Increased risk of stroke in older women should be taken into account in prescribing decisions.
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.