| Lonquex |
Human |
lipegfilgrastim |
lipegfilgrastim |
EMEA/H/C/002556 |
Teva B.V. |
2013/07/25
|
Authorised |
| Aftovaxpur DOE |
Veterinary |
inactivated vaccine against foot-and-mouth disease |
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063. |
EMEA/V/C/002292 |
Boehringer Ingelheim Vetmedica GmbH |
2013/07/15
|
Withdrawn |
| Erivedge |
Human |
vismodegib |
vismodegib |
EMEA/H/C/002602 |
Roche Registration GmbH |
2013/07/12
|
Authorised |
| Iclusig |
Human |
ponatinib |
ponatinib |
EMEA/H/C/002695 |
Incyte Biosciences Distribution B.V. |
2013/07/01
|
Authorised |
| Imatinib Accord |
Human |
imatinib |
imatinib |
EMEA/H/C/002681 |
Accord Healthcare S.L.U. |
2013/06/30
|
Authorised |
| Maci |
Human |
matrix-applied characterised autologous cultured chondrocytes |
autologous cultured chondrocytes |
EMEA/H/C/002522 |
Vericel Denmark ApS |
2013/06/27
|
Expired |
| Stayveer |
Human |
bosentan monohydrate |
bosentan (as monohydrate) |
EMEA/H/C/002644 |
Janssen-Cilag International NV |
2013/06/24
|
Authorised |
| 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Withdrawn |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Withdrawn |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 |
| HyQvia |
Human |
human normal immunoglobulin |
human normal immunoglobulin |
EMEA/H/C/002491 |
Baxalta Innovations GmbH |
2013/05/16
|
Authorised |
| Voriconazole Accord |
Human |
voriconazole |
voriconazole |
EMEA/H/C/002669 |
Accord Healthcare S.L.U. |
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 |
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