MYCOSTATIN Oral suspension Ref.[49859] Active ingredients: Nystatin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Substipharm, 24 rue Erlanger, 75016 Paris, France

Product name and form

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

Pharmaceutical Form

Oral suspension.

Light creamy, yellow suspension.

Qualitative and quantitative composition

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

Excipient(s) with known effect:

Ethanol (8.06 mg/ml)
Sucrose (500 mg/ml)
Sodium (1 mg/ml)
Methyl parahydroxybenzoate (E218, 1.0 mg/ml)
Propyl parahyrdroxybenzoate (E216, 0.2 mg/ml)

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

Cherry flavour
Cinnamic aldehyde
Ethanol
Glycerol
Methyl parahydroxybenzoate (E218)
Peppermint oil
pH adjusters (hydrochloric acid, sodium hydroxide)
Propyl parahydroxybenzoate (E216)
Sodium carboxymethycellulose (E466)
Anhydrous disodium phosphate
Sucrose
Purified water

Pack sizes and marketing

30 ml Type III amber glass bottle with polypropylene cap, packed in a cardboard carton with a graduated, polyethylene dropper with natural rubber bulb.

Marketing authorization holder

Substipharm, 24 rue Erlanger, 75016 Paris, France

Marketing authorization dates and numbers

PA1677/007/007

Date of first authorisation: 01 April 1977
Date of last renewal: 01 April 2007

Drugs

Drug Countries
MYCOSTATIN Austria, Australia, Spain, Ireland, New Zealand

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