| 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Withdrawn |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Withdrawn |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Withdrawn |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 |
| Perjeta |
Human |
pertuzumab |
pertuzumab |
EMEA/H/C/002547 |
Roche Registration GmbH |
2013/03/04
|
Authorised |
| Selincro |
Human |
nalmefene |
nalmefene hydrochloride dihydrate |
EMEA/H/C/002583 |
H. Lundbeck A/S |
2013/02/24
|
Authorised |
| Adasuve |
Human |
loxapine |
loxapine |
EMEA/H/C/002400 |
Ferrer Internacional S.A. |
2013/02/20
|
Authorised |
| Zaltrap |
Human |
aflibercept |
aflibercept |
EMEA/H/C/002532 |
Sanofi Winthrop Industrie |
2013/02/01
|
Authorised |
| Lyxumia |
Human |
lixisenatide |
lixisenatide |
EMEA/H/C/002445 |
Sanofi Winthrop Industrie |
2013/01/31
|
Withdrawn |
| Ryzodeg |
Human |
insulin degludec;insulin aspart |
insulin aspart;insulin degludec |
EMEA/H/C/002499 |
Novo Nordisk A/S |
2013/01/21
|
Authorised |
| BindRen |
Human |
colestilan |
colestilan |
EMEA/H/C/002377 |
Mitsubishi Pharma Europe Ltd |
2013/01/21
|
Withdrawn |
| Tresiba |
Human |
insulin degludec |
insulin degludec |
EMEA/H/C/002498 |
Novo Nordisk A/S |
2013/01/20
|
Authorised |
| Amyvid |
Human |
florbetapir (18F) |
florbetapir (18F) |
EMEA/H/C/002422 |
Eli Lilly Nederland B.V. |
2013/01/14
|
Authorised |