Ibandronic Acid Teva

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ibandronic 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 Ibandronic Acid Teva. 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 Ibandronic Acid Teva.

This EPAR was last updated on 22/11/2022

Authorisation details

Product details
Name
Ibandronic Acid Teva
Agency product number
EMEA/H/C/001195
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Fractures, Bone
  • Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
M05BA06
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
17/09/2010
Contact address
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

22/11/2022 Ibandronic Acid Teva - EMEA/H/C/001195 - IB/0020

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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

Ibandronic acid 50mg

Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Ibandronic acid 150mg

Treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Assessment history

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