Overview
The marketing authorisation for Zoledronic acid Teva Pharma has been withdrawn at the request of the marketing authorisation holder.
Zoledronic acid Teva Pharma : EPAR - Summary for the public
Product information
Zoledronic acid Teva Pharma : EPAR - Product Information
Latest procedure affecting product information: R/0014
18/01/2018
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use
Product details
- Name of medicine
- Zoledronic acid Teva Pharma
- Active substance
- zoledronic acid
- International non-proprietary name (INN) or common name
- zoledronic acid
- Therapeutic area (MeSH)
- Osteoporosis
- Osteitis Deformans
- Osteoporosis, Postmenopausal
- Anatomical therapeutic chemical (ATC) code
- M05BA08
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic indication
Treatment of osteoporosis:
- in post-menopausal women;
- in men;
at increased risk of fracture including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:
- in post-menopausal women;
- in men;
at increased risk of fracture.
Treatment of Paget’s disease of the bone in adults.
Assessment history
Zoledronic acid Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation