AVEO Pharmaceuticals, Inc. (AVEO)

[Biotech Pharmer]

Dear Mr XXXXXX,
Thank you for your enquiry of 24 June 2017 regarding the number of medicines that have received a positive opinion from CHMP but then failed to obtain a marketing authorisation.
Please note that currently no medicine has obtained a positive CHMP recommendation and was then subsequently refused marketing authorisation.
However, a number of marketing authorisation applications have actually been withdrawn after the CHMP issued a positive recommendation and before the European Commission could make a decision on the marketing authorisation:
Desloratadine Krka (desloratadine)
Egranli (balugrastim)
Folcepri (etarfolatide)
Ibandronic Acid Hexal (ibandronic acid)
Lunivia (eszopiclone)
Neocepri (folic acid)
Pioglitazone ratio (pioglitazone)
Pioglitazone ratiopharm (pioglitazone)
Pioglitazone ratiopharm GmbH (pioglitazone)
Pioglitazone Teva Generics (pioglitazone)
ratioepo (epoetin theta)
Vynfinit (vintafolide)
Desloratadine Krka (desloratadine)
Egranli (balugrastim)
We hope you find this information helpful. We would be grateful if you could take part in a short survey on our service, which you can access through the following link:
https://ec.europa.eu/eusurvey/runner/AskEMA
With kind regards,
Inga Abed


European Medicines Agency
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom