ZOLEDRONIC ACID HOSPIRA 4mg/100ml Solution for infusion Ref.[7895] Active ingredients: Zoledronic acid

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine, 17 1050, Bruxelles, Belgium

Product name and form

Zoledronic Acid Hospira 4 mg/100 ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear and colourless solution.

Qualitative and quantitative composition

One bag with 100 ml contains 4 mg zoledronic acid (as monohydrate).

One ml of the solution contains 0.04 mg zoledronic acid (as monohydrate).

Excipient with known effect: Zoledronic Acid Hospira 4 mg/100 ml contains 360 mg sodium per dosage unit.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zoledronic acid

Zoledronic acid belongs to the class of bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclastic bone resorption.

List of Excipients

Mannitol
Sodium citrate
Sodium chloride
Water for injections

Pack sizes and marketing

100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap.

Pack size: Zoledronic Acid Hospira is supplied as packs containing 1 bag.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine, 17 1050, Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/12/800/003

Date of first authorisation: 19 November 2012
Date of latest renewal: 24 August 2017

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