| 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Withdrawn |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 |
| Memantine Merz |
Human |
memantine hydrochloride |
memantine hydrochloride |
EMEA/H/C/002711 |
Merz Pharmaceuticals GmbH |
2012/11/22
|
Authorised |
| Eylea |
Human |
aflibercept |
aflibercept |
EMEA/H/C/002392 |
Bayer AG |
2012/11/21
|
Authorised |
| Capecitabine Medac |
Human |
capecitabine |
capecitabine |
EMEA/H/C/002568 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2012/11/19
|
Authorised |
| Zoledronic Acid Hospira |
Human |
zoledronic acid |
zoledronic acid monohydrate |
EMEA/H/C/002365 |
Pfizer Europe MA EEIG |
2012/11/19
|
Authorised |
| Ibandronic acid Accord |
Human |
ibandronic acid |
ibandronic acid |
EMEA/H/C/002638 |
Accord Healthcare S.L.U. |
2012/11/18
|
Authorised |
| Picato |
Human |
ingenol mebutate |
Ingenol mebutate |
EMEA/H/C/002275 |
LEO Laboratories Ltd. |
2012/11/15
|
Withdrawn |
| Forxiga |
Human |
dapagliflozin |
dapagliflozin propanediol monohydrate |
EMEA/H/C/002322 |
AstraZeneca AB |
2012/11/11
|
Authorised |
| Adcetris |
Human |
brentuximab vedotin |
Brentuximab vedotin |
EMEA/H/C/002455 |
Takeda Pharma A/S |
2012/10/25
|
Authorised |
| Glybera |
Human |
alipogene tiparvovec |
alipogene tiparvovec |
EMEA/H/C/002145 |
uniQure biopharma B.V. |
2012/10/25
|
Expired |
| Xalkori |
Human |
crizotinib |
crizotinib |
EMEA/H/C/002489 |
Pfizer Europe MA EEIG |
2012/10/23
|
Authorised |
| Enurev Breezhaler |
Human |
glycopyrronium bromide |
glycopyrronium bromide |
EMEA/H/C/002691 |
Novartis Europharm Ltd |
2012/09/28
|
Authorised |
| Tovanor Breezhaler |
Human |
glycopyrronium bromide |
glycopyrronium bromide |
EMEA/H/C/002690 |
Novartis Europharm Limited |
2012/09/28
|
Authorised |
| Seebri Breezhaler |
Human |
glycopyrronium bromide |
glycopyrronium bromide |
EMEA/H/C/002430 |
Novartis Europharm Limited |
2012/09/28
|
Authorised |
| Dacogen |
Human |
decitabine |
decitabine |
EMEA/H/C/002221 |
Janssen-Cilag International N.V. |
2012/09/20
|
Authorised |