| 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Withdrawn |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Withdrawn |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Withdrawn |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 |
| Bexsero |
Human |
meningococcal group B Vaccine (rDNA, component, adsorbed) |
outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254);recombinant Neisseria meningitidis group B fHbp fusion protein;recombinant Neisseria meningitidis group B NadA protein;recombinant Neisseria meningitidis group B NHBA fusion protein |
EMEA/H/C/002333 |
GSK Vaccines S.r.l. |
2013/01/13
|
Authorised |
| Krystexxa |
Human |
pegloticase |
pegloticase |
EMEA/H/C/002208 |
Crealta Pharmaceuticals Ireland Limited |
2013/01/08
|
Withdrawn |
| Imatinib Teva |
Human |
imatinib |
imatinib |
EMEA/H/C/002585 |
Teva B.V. |
2013/01/07
|
Authorised |
| Betmiga |
Human |
mirabegron |
Mirabegron |
EMEA/H/C/002388 |
Astellas Pharma Europe B.V. |
2012/12/20
|
Authorised |
| NexoBrid |
Human |
concentrate of proteolytic enzymes enriched in bromelain |
proteolytic enzymes enriched in bromelain |
EMEA/H/C/002246 |
MediWound Germany GmbH |
2012/12/18
|
Authorised |
| Constella |
Human |
linaclotide |
linaclotide |
EMEA/H/C/002490 |
AbbVie Deutschland GmbH & Co. KG |
2012/11/26
|
Authorised |