NYSTAN Oral suspension Ref.[7711] Active ingredients: Nystatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Vygoris Limited, 930 High Road, London N12 9RT, United Kingdom

Product name and form

Nystan 100,000 units/ml Oral Suspension (Ready-Mixed).

Pharmaceutical Form

Oral suspension.

Qualitative and quantitative composition

Ready mixed oral suspension containing 100,000 units nystatin per ml.

Excipient(s) with known effect: ethanol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium and sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nystatin

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

List of Excipients

Ethanol
Flavours
Glycerin
Methyl parahydroxybenzoate (E218)
pH adjusters (hydrochloric acid, sodium hydroxide)
Propyl parahydroxybenzoate (E216)
Sodium carboxymethylcellulose (E466)
Sodium phosphate
Sucrose
Water

Pack sizes and marketing

30 ml amber glass bottle, packed in a cardboard carton with a graduated, polyethylene dropper.

Marketing authorization holder

Vygoris Limited, 930 High Road, London N12 9RT, United Kingdom

Marketing authorization dates and numbers

PL 47587/0005

Date of first authorisation: 28 November 1990
Date of latest renewal: 08 February 2010

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