EMA approval process

[kylix]

Does anyone please know how long it takes for EMA (European medical agency) to approve something?
Ikervis (formerly known as cyclokat) has been applied for approval at the beginning of december 2013, but nothing has happened since then. I thought EMA worked faster than FDA, but it may not be true

[RFREITAS]

Have no idea

But maybe if you send an e-mail to the company they can replay.

[RFREITAS]

It seems like is going to be available next summer:

http://www.ukmi.nhs.uk/applications/...newDrugID=5933

[RFREITAS]

News about it:

http://www.ema.europa.eu/ema/index.j...01ac058001d127

Also their (EMA) reply:

Thank you for your enquiry of 18 December 2014 regarding the evaluation of ciclosporin.
Please note that the European Medicines Agency (EMA) has now completed the evaluation of Ikervis (ciclosporin) for the treatment of severe keratitis (inflammation of the eye) in patients with dry eye disease, and has recommended that it be authorised for such use in the European Union (EU). For more information, please see here:
http://www.ema.europa.eu/ema/index.j...01ac058001d127
The EMA recommendation has been forwarded to the European Commission, the body with the authority to grant the marketing authorisation of medicines in the EU. A decision is expected within the next 2 months, after which further information on Ikervis and its scientific evaluation by the EMA will be published on the EMA website.
Please however note that once a medicine has received a marketing authorisation in the EU, it is up to the company to decide when and in which countries the medicine will be marketed.
We hope you find this information helpful and we would be grateful for any feedback you may have as this will help us to improve our service. We therefore invite you to take part in our survey which you can access through the following link: https://www.surveymonkey.com/s/HZ8LWSC

Have a nice week!

[RFREITAS]

More info:

http://globenewswire.com/news-releas...orization.html

Does anyone knows when it will be available?

Have a nice day!