MONOVO Cream Ref.[49808] Active ingredients: Mometasone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2017  Publisher: Almirall Hermal GmbH, ScholtzstraรŸe 3, D-21465 Reinbek, Germany Phone: +49 40 727 04 0 Fax: +49 40 72 704 329 E-mail: info@almirall.de

Product name and form

Monovo 1mg/g Cream.

Pharmaceutical Form

Cream.

A white cream.

Qualitative and quantitative composition

One gram of cream contains 1 mg of mometasone furoate (0.1% mometasone furoate).

Excipients with known effect: 72.00 mg of cetostearyl alcohol (type A), emulsifying; 10.00 mg of cetyl alcohol and 13 microgram of butylated hydroxytoluene /1 gram cream.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mometasone

Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade.

List of Excipients

Purified water
White soft paraffin (contains butylated hydroxytoluene (E321) as antioxidant)
Liquid paraffin
2-Methylpentane-2,4-diol
Emulsifying cetostearyl alcohol (type A, contains disodium/potassium hydrogen phosphate for pH adjustment)
Macrogol cetostearyl ether
Cetyl alcohol
Glycerol
Anhydrous citric acid
Sodium citrate
Xanthan gum

Pack sizes and marketing

The cream is filled in PE/aluminium laminate tubes fitted with a white polypropylene screw cap in a cardboard carton.

Carton of 1 tube.

Tubes with 10g, 15g, 20g, 25g, 30g, 35g, 50g, 60g, 70g, 90g and 100g of cream.

Not all pack sizes may be marketed.

Marketing authorization holder

Almirall Hermal GmbH, ScholtzstraรŸe 3, D-21465 Reinbek, Germany
Phone: +49 40 727 04 0
Fax: +49 40 72 704 329
E-mail: info@almirall.de

Marketing authorization dates and numbers

PA 1548/002/001

Date of first authorisation: 18th November 2011
Date of last renewal: 10th March 2016

Drugs

Drug Countries
MONOVO Austria, Germany, Ireland

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