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Ferriprox 100 mg/ml oral solution (2012)

Active ingredients: Deferiprone

Product Name and Form

Ferriprox 100 mg/ml oral solution.

Pharmaceutical form

Oral solution.

Clear, reddish orange coloured liquid.

Qualitative and Quantitative Composition

Each ml of oral solution contains 100 mg deferiprone (25 g deferiprone in 250 ml and 50 g deferiprone in 500 ml).

Excipient: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).

For a full list of excipients, see section 6.1.

Chemical substance
Description
Deferiprone

Deferiprone is a bidentate ligand which binds iron in a 3:1 molar ratio. Deferiprone monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.

List of excipients

Purified water
Hydroxyethylcellulose
Glycerol
Hydrochloric acid, concentrated
Artificial cherry flavour
Peppermint oil
Sunset Yellow (E110)
Sucralose (E955)

Pack sizes and Marketing

Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).

Each pack contains one bottle of 250 ml or 500 ml oral solution.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
Netherlands

Date of first authorisation: 25/08/1999

Date of latest renewal: 25/08/2009

Marketing authorization number:

EU/1/99/108/002

EU/1/99/108/003