ROSICED Cream Ref.[6988] Active ingredients: Methronidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Pierre Fabre Dermatologie, 45 place Abel Gance, 92100 Boulogne, France

Product name and form

ROSICED 7.5 mg/g Cream.

Pharmaceutical Form

Cream.

Smooth white to off-white cream.

Qualitative and quantitative composition

1 g of cream contains 7.5 mg of metronidazole (0.75% m/m).

For excipients, see 6.1.

Active Ingredient Description
Methronidazole

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

List of Excipients

Glyceryl monolaurate
Glyceryl monomyristate
Propylene glycol
Citric acid anhydrous (pH adjuster)
Sodium hydroxide (pH adjuster)
Carbomers
Purified water

Pack sizes and marketing

MDPE tubes fitted with polypropylene caps containing 25 g, 30 g, 40 g or 50 g of cream.

Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Dermatologie, 45 place Abel Gance, 92100 Boulogne, France

Marketing authorization dates and numbers

PL 20693/0007

Date of first authorisation: 05/12/2001
Date of renewal: 06/06/2007

Drugs

Drug Countries
ROSICED Netherlands, United Kingdom

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