Zoledronic Acid Hospira

Withdrawn

This medicine's authorisation has been withdrawn

zoledronic acid

Overview

On 22 February 2024, the European Commission withdrew the marketing authorisation for Zoledronic acid Hospira (zoledronic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pfizer Europe MA EEIG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Zoledronic acid Hospira was granted marketing authorisation in the EU on 19 November 2012 for the prevention of bone complications in adults with advanced cancer that is affecting the bone, and for the treatment of hypercalcaemia caused by tumours. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. 

Zoledronic Acid Hospira : EPAR - Summary for the public

Reference Number: EMA/623949/2012

Product information

Zoledronic Acid Hospira : EPAR - Product Information

Zoledronic Acid Hospira : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zoledronic Acid Hospira
• Active substance:
  zoledronic acid monohydrate
• International non-proprietary name (INN) or common name:
  zoledronic acid
• Therapeutic area (MeSH):
  Hypercalcemia
• Anatomical therapeutic chemical (ATC) code:
  M05BA08

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

4 mg / 5 ml and 4 mg / 100 ml:

• Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
• Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

5 mg / 100 ml:

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002365
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Marketing authorisation issued:
  19/11/2012
• Withdrawal of marketing authorisation:
  22/02/2024
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Zoledronic Acid Hospira : EPAR - Procedural steps taken and scientific information after authorisation

Zoledronic Acid Hospira-H-C-PSUSA-3149-01608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/321882/2017

Initial marketing authorisation documents

Zoledronic Acid Hospira : EPAR - Public assessment report

Adopted Reference Number: EMA/711812/2012

CHMP summary of positive opinion for Zoledronic acid Hospira

Adopted Reference Number: EMA/CHMP/604898/2012