Regulatory PathRegulatory requirements compared

Active substance

Strontium ranelate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PROTELOS 2GM GRANULES FOR ORAL SUSP.2 gGranules for oral suspension · Oral use28 SachetSAR 229.50NCE · PrescriptionSERVIERWithdrawn by regulatory authority · Not Marketed

EMA European Union — centrally authorised medicines

Protelos Les Laboratoires Servier · Withdrawn · authorised 20 Sep 2004 · ATC M05BX03

Therapeutic indication (EMA)

Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.

Osseor Les Laboratoires Servier · Withdrawn · authorised 20 Sep 2004 · ATC M05BX03

Therapeutic indication (EMA)

Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.

Safety signals and safety-related labeling changes

All safety entries for strontium ranelate →

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.