Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Apotex Europe B.V. Darwinweg 20 2333 CR Leiden Netherlands
Ferriprox 100 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, reddish orange coloured liquid. |
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.
| Active Ingredient | 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 |
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.
Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
Netherlands
EU/1/99/108/002
EU/1/99/108/003
Date of first authorisation: 25/08/1999
Date of latest renewal: 25/08/2009
| Drug | Countries | |
|---|---|---|
| FERRIPROX | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States |
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