PANRETIN Gel Ref.[6133] Active ingredients: Alitretinoin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eisai GmbH, Lyoner StraรŸe 36, 60528, Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net

Product name and form

Panretin 0.1% gel.

Pharmaceutical Form

Gel.

Clear yellow gel.

Qualitative and quantitative composition

1 g of gel contains 1 mg alitretinoin (0.1%).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alitretinoin

Alitretinoin is a naturally-occurring endogenous hormone related to vitamin A, binds to and activates all known intracellular retinoid receptor subtypes (RAR, RAR, RAR, RXR, RXR, RXR). The efficacy of alitretinoin in treating KS lesions may be related to the demonstrated ability of alitretinoin to inhibit the in vitro growth of KS cells.

List of Excipients

Ethanol
Macrogol 400
Hydroxypropylcellulose
Butylhydroxytoluene

Pack sizes and marketing

Panretin gel is supplied in a multi-use 60 g epoxy-lined aluminium tube.

Each carton contains one tube of gel.

Marketing authorization holder

Eisai GmbH, Lyoner StraรŸe 36, 60528, Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net

Marketing authorization dates and numbers

EU/1/00/149/001

Date of first authorization: 11 October 2000
Date of latest renewal: 27 September 2010

Drugs

Drug Countries
PANRETIN Estonia, Lithuania, Poland, United States

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