Aclasta

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zoledronic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Aclasta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aclasta.

This EPAR was last updated on 16/01/2023

Authorisation details

Product details
Name
Aclasta
Agency product number
EMEA/H/C/000595
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
Publication details
Marketing-authorisation holder
Sandoz Pharmaceuticals d.d.
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
15/04/2005
Contact address

Verovškova ulica 57
1000 Ljubljana
SLOVENIA

Product information

16/01/2023 Aclasta - EMEA/H/C/000595 - N/0080

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic 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 and in men at increased risk of fracture.

Treatment of Paget's disease of the bone.

Assessment history

Changes since initial authorisation of medicine

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