Mirvaso European Availability by March 2014


EMA

A Medscape article today announces that Mirvaso has been granted human approval and should be approved for sale across Europe by March 2014.

The initial authorisation to market Mirvaso has been granted and are normally issued 67 days from the adoption of the `Summary of opinion

Mirvaso Gains CHMP Support for Rosacea Erythema Treatment

Miriam E. Tucker

December 20, 2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing of brimonidine tartrate 3 mg/g topical gel (Mirvaso, Galderma) for the symptomatic treatment of facial erythema of rosacea in adult patients.

“The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Mirvaso and therefore recommends the granting of the marketing authorization,” the committee said in a statement.

The CHMP is the committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for human use.

Pharmacovigilance

The announcement mentions that Mirvaso will be subject to a pharmacovigilance plan where adverse events will be collected and analysed.

The most common local adverse events associated with topical use of brimonidine tartrate are erythema, pruritus, flushing, and skin burning sensation. A pharmacovigilance plan for the product will be implemented as part of the marketing authorization.

This is a good development because as we have been in the later half of 2013, the online reports from users of Mirvaso do not match the efficacy and safety of the Phase 3 Trials.

It is still unclear why this appears to be so, but many adverse reactions, often described as rebound flushing are being reported, seemingly in a much greater frequency that the around 5% seen in the large scale trial participants.

Perhaps some more insight into adverse reactions to Mirvaso will surface as safety data is collected on a wider scale.

When will Mirvaso be available in Europe?

Detailed recommendations for brimonidine’s use will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission, which is expected within 67 days.

If you take December 20 as the CHMP approval, then 67 days later brings us to near the beginning of March 2014.

Marketing authorisation, as recommended by the CHMP is  “approval to market a medicine in one, several or all European Union Member States”.

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About the Author

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

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5 Reader Comments

  1. John says:

    It should never be released anywhere else.Its a walking disaster.

    • Warren says:

      Have you tried it John??

      • John says:

        Yes I did and I had to stop using it after 3 days . Its one of the biggest mistakes I have ever made.Never ever go near this product thats the best advice I can give anyone .I really wished I had of listened to people in the first place who warned me off it .

  2. emily says:

    I’ve been using it for over 2 months. It has really helped me (and my friends).

  3. Jonny says:

    I couldn’t wait till got approved in uk so imported some from USA (I am in uk) omg what a mistake but at least i now know.
    This is a nasty nasty bad product – rebound flushing is just horrendous. You have 6 or so hours of releif and then BANG – you look like you have been burnt with a blow torch. Makes me so sad and angry as I have waited years for this product.
    My advice – don’t try it but if you really have to do it a little at a time and when you have time off work etc as you won’t want to face people when the rebound kicks in.

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