FOSRENOL Oral powder Ref.[8720] Active ingredients: Lanthanum

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Takeda UK Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom

Product name and form

Fosrenol 750 mg oral powder.

Pharmaceutical Form

Oral Powder.

White to off-white powder.

Qualitative and quantitative composition

Each sachet contains 750 mg lanthanum (as lanthanum carbonate hydrate).

Excipient(s) with known effect: Each sachet also contains 641.7 mg dextrates, containing glucose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lanthanum

Lanthanum is indicated as a phosphate binding agent for use in the control of hyperphosphataemia.

List of Excipients

Dextrates (hydrated)
Colloidal anhydrous silica
Magnesium stearate

Pack sizes and marketing

2.1 g of oral powder in sachets formed from a polyethylene terephthalate/aluminium/polyethylene laminate.

Pack size: 90 sachets (Outer carton contains 9 cartons of 10 sachets).

Marketing authorization holder

Takeda UK Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom

Marketing authorization dates and numbers

PL 16189/0141

Date of first authorisation: 13/04/2012
Date of latest renewal: 19/03/2012

Drugs

Drug Countries
FOSRENOL Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa

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