Is Zolendric acid approved in European Union?

Yes. EMA authorised it on 20 March 2001.

Who is the marketing authorisation holder for Zolendric acid in European Union?

Phoenix Labs Unlimited Company holds the EU marketing authorisation.

Zolendric acid in European Union — EU regulatory status, approvals & guidance

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA — authorised 20 March 2001

Application: EMEA/H/C/000336
Marketing authorisation holder: Phoenix Labs Unlimited Company
Local brand name: Zometa
Indication: Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or
Status: approved

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🇪🇺 Zolendric acid in European Union

Marketing authorisation

EMA — authorised 20 March 2001

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