Onzeald |
Human |
etirinotecan pegol |
etirinotecan pegol |
EMEA/H/C/003874 |
Nektar Therapeutics UK Limited |
|
Refused |
EnCyzix |
Human |
enclomifene |
enclomifene citrate |
EMEA/H/C/004198 |
Renable Pharma Limited |
|
Refused |
Adlumiz |
Human |
anamorelin |
anamorelin hydrochloride |
EMEA/H/C/003847 |
|
|
Refused |
Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech |
Human |
human IgG1 monoclonal antibody specific for human interleukin-1 alpha |
human IgG1 monoclonal antibody specific for human interleukin-1 alpha |
EMEA/H/C/004388 |
XBiotech Germany GmbH |
|
Refused |
Ipique |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005433 |
Rotterdam Biologics B.V. |
|
Refused |
Genasense |
Human |
oblimersen |
oblimersen |
EMEA/H/C/000711 |
Genta Development Ltd. c/o Ross Craig |
|
Refused |
Gemesis |
Human |
becaplermin |
becaplermin |
EMEA/H/C/000997 |
BioMimetic Therapeutics Ltd |
|
Refused |
Dropcys |
Human |
mercaptamine |
mercaptamine |
EMEA/H/C/004038 |
Lucane Pharma |
|
Refused |
Lodipressin |
Veterinary |
amlodipine |
Amlodipine besilate |
EMEA/V/C/003786 |
Le Vet Beheer B.V. |
|
Refused |
Hopveus |
Human |
sodium oxybate |
sodium oxybate |
EMEA/H/C/004962 |
D&A Pharma |
|
Refused |
Cimzia |
Human |
certolizumab pegol |
Certolizumab pegol |
EMEA/H/C/000740 |
UCB Pharma SA |
|
Refused |
Natalizumab Elan Pharma |
Human |
natalizumab |
natalizumab |
EMEA/H/C/000624 |
Elan Pharma International Ltd. |
|
Refused |
Mylotarg |
Human |
gemtuzumab ozogamicin |
gemtuzumab ozogamicin |
EMEA/H/C/000705 |
Wyeth Europa Ltd |
|
Refused |
Mycograb |
Human |
efungumab |
recombinant human monoclonal antibody to hsp |
EMEA/H/C/000658 |
NeuTec Pharma plc |
|
Refused |
Veraflox |
Veterinary |
pradofloxacin |
pradofloxacin |
EMEA/V/C/000099 |
Bayer HealthCare AG |
|
Refused |
Valdoxan |
Human |
Agomelatine |
Agomelatine |
EMEA/H/C/000656 |
Les Laboratoires Servier |
|
Refused |
Thymanax |
Human |
Agomelatine |
Agomelatine |
EMEA/H/C/000657 |
Les Laboratoires Servier |
|
Refused |
Alpheon |
Human |
interferon alfa-2a |
recombinant human interferon alfa-2a |
EMEA/H/C/000585 |
BioPartners GmbH |
|
Refused |
Tolvaptan Accord |
Human |
tolvaptan |
Tolvaptan |
EMEA/H/C/005961 |
Accord Healthcare S.L.U. |
|
Authorised |
Omblastys |
Human |
iodine (131I) omburtamab |
iodine (131I) omburtamab |
EMEA/H/C/005499 |
Y-Mabs Therapeutics A/S |
|
Refused |