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Iasibon (ibandronic acid)

Generic
Region
🇪🇺 EU
Active substance
ibandronic acid
Company
Pharmathen S.A.
Status
Authorised
Therapeutic area
Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
CHMP opinion
Thu 21 Oct 2010
EU approval
Fri 21 Jan 2011
Designations
Generic
Application
EMEA/H/C/002025
ATC
M05BA06
Official record
www.ema.europa.eu

Indication

Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.