Mirvaso has been approved across Europe

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News today that Mirvaso has gained approval  or Marketing Authorisation as they call it, by the European Commission.

This means that Mirvaso is approved for sale and will soon be available across the European Community, at the will and availability of Galderma.

So Mirvaso is now approved for sale in Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lichenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

If you live in the EU do please let us know when you are able to get hold of it and more importantly let us know if Mirvaso works for you or not !

Press Release

Mirvaso (Brimonidine) The First And Only Treatment Targeting The Facial Redness Of Rosacea Approved By The European Commission

Galderma portfolio expands to offer a fast onset and long-acting alpha-2 adrenergic receptor agonist

LAUSANNE, Switzerland – February 26, 2014, /PRNewswire/— Galderma, a leading global pharmaceutical company exclusively focused on dermatology, today announced that the European Commission has granted Marketing Authorisation in Europe for Mirvaso(brimonidine) 3 mg/g gel.

Mirvaso is an alpha-2 adrenergic receptor agonist that acts rapidly and can last for up to 12 hours. It is indicated for the symptomatic treatment of facial erythema (redness) of rosacea in adult patients.

Mirvaso is the only approved medicinal product that directly targets the facial redness of rosacea and provides an innovative therapy for the condition. Applied once-daily, Mirvasoworks quickly to reduce the redness of rosacea,” said Humberto C. Antunes, President and CEO of Galderma. “This is yet another milestone in Galderma’s continued R&D commitment to address the unmet needs of patients with skin conditions.”

The European Commission decision to grant Marketing Authorisation in Europe for Mirvasois based on data collected from 553 patients enrolled in two phase 3 clinical trials of one-month duration. The results from both studies showed that adults with rosacea erythema who used Mirvaso demonstrated significantly greater reduction of the facial redness than the ones who applied vehicle gel only. In addition, a long-term study in 449 subjects who used Mirvaso for up to 12-months demonstrated that Mirvaso was effective and well tolerated.

Marketing Authorisation in Europe for Mirvaso® is applicable to the 28 Member States of the European Union, as well as Iceland, Lichtenstein and Norway.

About Mirvaso(brimonidine)

Mirvaso (brimonidine) 3 mg/g gel is an alpha-2 adrenergic agonist indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.

Mirvaso is the proprietary name endorsed by the European Medicines Agency (EMA) for brimonidine.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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2 Reader Comments

  1. aileen glover says:

    I have been to get BRIMONIDINE at a compounding chemist in Canberra. Helps redness at the time quite well but I don’t think it prevents it coming back again.But I can go out without looking like a tomato–or sometimes even a beetroot

  2. sestaliuc rodica says:

    I live in romania. How can i order mirvaso?

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