European Medicines Agency - Human Medicines - Refusals - Medicinal Products

Refusals - Medicinal Products for Human Use

Medicinal Products
Initial negative
opinion Product INN Outcome*
23/04/2009 Lyrica INN: pregabalin (extension of indication) Re-examination in progress
19/02/2009 Biferonex INN: interferon beta-1a Re-examination in progress
22/01/2009 Vedrop INN: tocofersolan Re-examination in progress
20/11/2008 Ixempra INN: ixabepilone Re-examination in progress
23/10/2008 Xeristar INN: duloxetine (extension of indication) Marketing authorisation refused
23/10/2008 Cymbalta INN: duloxetine (extension of indication) Marketing authorisation refused
24/07/2008 Sovrima INN: idebenone Marketing authorisation refused
24/07/2008 Taxotere INN: docetaxel (extension of indication) Application withdrawn
24/07/2008 Docetaxel Winthrop INN: docetaxel (extension of indication) Application withdrawn
30/05/2008 Ramelteon INN: ramelteon Application withdrawn
24/01/2008 Lenalidomide Celgene Europe
INN: lenalinomide Application withdrawn
13/12/2007 Kiacta INN: eprodisate disodium Application withdrawn
13/12/2007 Rhucin INN: recombinant human C1 inhibitor Marketing authorisation refused
15/11/2007 CIMZIA INN: certolizumab pegol Marketing authorisation refused
18/10/2007 Zavesca INN: miglustat (extension of indication) Application withdrawn
20/09/2007 NutropinAq INN: somatropin (extension of indication) Application withdrawn
20/09/2007 Mylotarg INN: gemtuzumab ozogamicin Marketing authorisation refused
19/07/2007 Natalizumab Elan Pharma 300 mg INN: natalizumab Marketing authorisation refused
26/04/2007 Cerepro INN: adenovirus-mediated Herpes simplex virus-thymidine kinase gene Application withdrawn
26/04/2007 Genasense INN: oblimersen Marketing authorisation refused
16/11/2006 Mycograb INN: efungumab Marketing authorisation refused
27/07/2006 Thymanax INN: agomelatine Marketing authorisation refused
27/07/2006 Valdoxan INN: agomelatine Marketing authorisation refused
29/06/2006 Alpheon INN: interferon alfa-2a Marketing authorisation refused
15/12/2005 Zelnorm INN: tegaserod Marketing authorisation refused
* Possible outcomes are:

Pending: request for re-examination has not been received.
Re-examination in progress: a request for re-examination has been received, and is being assessed.
Marketing authorisation refused: the Commission Decision on the refusal has been issued.
Application withdrawn: the applicant has withdrawn its application for a marketing authorisation after the time of the initial opinion.

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European Medicines Agency - Human Medicines - Refusals - Medicinal Products