BONDRONAT Film-coated tablets Ref.[7989] Active ingredients: Ibandronic acid

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands

Product name and form

Bondronat 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White to off-white film-coated tablets, of oblong shape engraved “L2” on one side and “IT” on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).

Excipients with known effect: Contains 88.1 mg lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibandronic acid

Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone. Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral. Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear. In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.

List of Excipients

Tablet core:

Lactose monohydrate
Povidone
Cellulose, microcrystalline
Crospovidone
Stearic acid
Silica, anhydrous colloidal

Tablet coat:

Hypromellose
Titanium dioxide (E171)
Talc
Macrogol 6000

Pack sizes and marketing

Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/96/012/009
EU/1/96/012/010

Date of first authorisation: 25 June 1996
Date of latest renewal: 25 June 2006

Drugs

Drug Countries
BONDRONAT Austria, Australia, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Singapore, Turkey, United Kingdom, South Africa

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