ALTARGO Ointment Ref.[8736] Active ingredients: Retapamulin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Altargo 10 mg/g ointment.

Pharmaceutical Form

Ointment.

Smooth, off-white ointment.

Qualitative and quantitative composition

Each gram of ointment contains 10 mg retapamulin (1% w/w).

Excipient(s) with known effect: Each gram of ointment contains up to 20 micrograms of butylated hydroxytoluene (E321).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Retapamulin

Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus. Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non-pleuromutilin antibacterial agents that interact with the ribosome.

List of Excipients

White soft paraffin
Butylated hydroxytoluene (E321)

Pack sizes and marketing

0.5 g aluminium foil sachet. Carton of 12 sachets.

5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube.

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

EU/1/07/390/001
EU/1/07/390/002
EU/1/07/390/003
EU/1/07/390/004

Date of first authorisation: 24 May 2007
Date of latest renewal: 20 April 2012

Drugs

Drug Countries
ALTARGO Brazil, Estonia, Lithuania

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