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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Zoledronic acid Accord This product is authorized under a different brandname in the EU in the folowing languages: - Ácido zoledrónico Accord (PT)|
|Auth. number :||EU/1/13/834|
|INN :||zoledronic acid|
|ATC:||Anatomical main group: M - Musculo-skeletal system|
Therapeutic subgroup: M05 - Drugs for treatment of bone diseases
Pharmacological subgroup: M05B - Drugs affecting bone structure and mineralization
Chemical subgroup: M05BA - Biphosphonates
Chemical substance: M05BA08 - Zoledronic acid
(See WHO ATC Index)
|Indication:||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).
|Marketing Authorisation Holder:||Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|21/01/2014||Centralised - Authorisation||EMEA/H/C/2667||(2014)317 of 16/01/2014|