| Nuedexta |
Human |
dextromethorphan hydrobromide;quinidine sulfate |
dextromethorphan;quinidine |
EMEA/H/C/002560 |
Jenson Pharmaceutical Services Limited |
2013/06/24
|
Withdrawn |
| Xtandi |
Human |
enzalutamide |
enzalutamide |
EMEA/H/C/002639 |
Astellas Pharma Europe B.V. |
2013/06/21
|
Authorised |
| Spedra |
Human |
avanafil |
avanafil |
EMEA/H/C/002581 |
Menarini International Operations Luxembourg S.A. |
2013/06/21
|
Authorised |
| Capecitabine SUN |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002050 |
Sun Pharmaceutical Industries Europe B.V. |
2013/06/21
|
Withdrawn |
| Memantine ratiopharm |
Human |
memantine |
memantine hydrochloride |
EMEA/H/C/002671 |
Ratiopharm GmbH |
2013/06/12
|
Authorised |
| Stribild |
Human |
elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil |
elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil fumarate |
EMEA/H/C/002574 |
Gilead Sciences Ireland UC |
2013/05/24
|
Authorised |
| Voriconazole Accord |
Human |
voriconazole |
voriconazole |
EMEA/H/C/002669 |
Accord Healthcare S.L.U. |
2013/05/16
|
Authorised |
| HyQvia |
Human |
human normal immunoglobulin |
human normal immunoglobulin |
EMEA/H/C/002491 |
Baxalta Innovations GmbH |
2013/05/16
|
Authorised |
| Marixino (previously Maruxa) |
Human |
memantine |
memantine hydrochloride |
EMEA/H/C/002658 |
KRKA, d.d. |
2013/04/28
|
Authorised |
| Nemdatine |
Human |
memantine |
memantine |
EMEA/H/C/002680 |
Actavis Group PTC ehf |
2013/04/22
|
Authorised |
| Memantine Mylan |
Human |
memantine |
memantine hydrochloride |
EMEA/H/C/002660 |
Mylan Pharmaceuticals Limited |
2013/04/21
|
Authorised |
| Memantine LEK |
Human |
memantine |
memantine hydrochloride |
EMEA/H/C/002630 |
Pharmathen S.A. |
2013/04/21
|
Withdrawn |
| Hexyon |
Human |
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) |
filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid |
EMEA/H/C/002796 |
Sanofi Winthrop Industrie |
2013/04/17
|
Authorised |
| Hexacima |
Human |
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) |
hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid |
EMEA/H/C/002702 |
Sanofi Winthrop Industrie |
2013/04/17
|
Authorised |
| Imatinib Actavis |
Human |
imatinib |
imatinib |
EMEA/H/C/002594 |
Actavis Group PTC ehf |
2013/04/17
|
Withdrawn |
| Ecoporc Shiga |
Veterinary |
genetically modified Shiga-toxin-2e antigen |
genetically modified recombinant Shiga-toxin-2e antigen |
EMEA/V/C/002588 |
|
2013/04/10
|
Authorised |
| Bosulif |
Human |
bosutinib |
bosutinib (as monohydrate) |
EMEA/H/C/002373 |
Pfizer Europe MA EEIG |
2013/03/27
|
Authorised |
| Tolucombi |
Human |
telmisartan;hydrochlorothiazide |
telmisartan;hydrochlorothiazide |
EMEA/H/C/002549 |
Krka, d.d., Novo mesto |
2013/03/13
|
Authorised |
| Jetrea |
Human |
ocriplasmin |
ocriplasmin |
EMEA/H/C/002381 |
Inceptua AB |
2013/03/13
|
Withdrawn |
| Actelsar HCT |
Human |
telmisartan;hydrochlorothiazide |
telmisartan;hydrochlorothiazide |
EMEA/H/C/002676 |
Actavis Group PTC ehf |
2013/03/13
|
Authorised |