NOXAFIL Oral suspension Ref.[8642] Active ingredients: Posaconazole

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Noxafil 40 mg/mL oral suspension.

Pharmaceutical Form

Oral suspension.

White suspension.

Qualitative and quantitative composition

Each mL of oral suspension contains 40 mg of posaconazole.

Excipient with known effect: This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Posaconazole

Posaconazole inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.

List of Excipients

Polysorbate 80
Simeticone
Sodium benzoate (E211)
Sodium citrate dihydrate
Citric acid monohydrate
Glycerol
Xanthan gum
Liquid glucose
Titanium dioxide (E171)
Artificial cherry flavour containing benzyl alcohol and propylene glycol
Purified water

Pack sizes and marketing

105 mL of oral suspension in a bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations: 2.5 mL and 5 mL.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/05/320/001

Date of first authorisation: 25 October 2005

Date of latest renewal: 25 October 2010

Drugs

Drug Countries
NOXAFIL Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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