| Kadcyla |
Human |
trastuzumab emtansine |
trastuzumab emtansine |
EMEA/H/C/002389 |
Roche Registration GmbH |
2013/11/15
|
Authorised |
| Invokana |
Human |
canagliflozin |
canagliflozin |
EMEA/H/C/002649 |
Janssen-Cilag International NV |
2013/11/15
|
Authorised |
| Fortacin |
Human |
lidocaine;prilocaine |
lidocaine;prilocaine |
EMEA/H/C/002693 |
Recordati Ireland Ltd. |
2013/11/15
|
Authorised |
| Abilify Maintena |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/002755 |
Otsuka Pharmaceutical Netherlands B.V. |
2013/11/14
|
Authorised |
| Xofigo |
Human |
radium Ra223 dichloride |
radium (223Ra) dichloride |
EMEA/H/C/002653 |
Bayer AG |
2013/11/13
|
Authorised |
| Relvar Ellipta |
Human |
fluticasone furoate;vilanterol |
fluticasone furoate;vilanterol |
EMEA/H/C/002673 |
GlaxoSmithKline Trading Services Limited |
2013/11/13
|
Authorised |
| NovoEight |
Human |
turoctocog alfa |
turoctocog alfa |
EMEA/H/C/002719 |
Novo Nordisk A/S |
2013/11/13
|
Authorised |
| Vitekta |
Human |
elvitegravir |
elvitegravir |
EMEA/H/C/002577 |
Gilead Sciences International Ltd |
2013/11/13
|
Withdrawn |
| Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) |
Human |
levodopa;carbidopa;entacapone |
levodopa;carbidopa;entacapone |
EMEA/H/C/002785 |
Orion Corporation |
2013/11/11
|
Authorised |
| Grastofil |
Human |
filgrastim |
filgrastim |
EMEA/H/C/002150 |
Accord Healthcare S.L.U. |
2013/10/18
|
Withdrawn |
| Defitelio |
Human |
defibrotide |
defibrotide |
EMEA/H/C/002393 |
Gentium S.r.l. |
2013/10/18
|
Authorised |
| Ovaleap |
Human |
follitropin alfa |
follitropin alfa |
EMEA/H/C/002608 |
Theramex Ireland Limited |
2013/09/27
|
Authorised |
| Giotrif |
Human |
afatinib |
afatinib |
EMEA/H/C/002280 |
Boehringer Ingelheim International GmbH |
2013/09/25
|
Authorised |
| Imatinib medac |
Human |
imatinib |
imatinib |
EMEA/H/C/002692 |
Medac |
2013/09/25
|
Withdrawn |
| Evarrest |
Human |
human fibrinogen;human thrombin |
human fibrinogen;human thrombin |
EMEA/H/C/002515 |
Omrix Biopharmaceuticals N. V. |
2013/09/25
|
Withdrawn |
| Ultibro Breezhaler |
Human |
indacaterol;glycopyrronium bromide |
indacaterol;glycopyrronium bromide |
EMEA/H/C/002679 |
Novartis Europharm Limited |
2013/09/19
|
Authorised |
| Tybost |
Human |
cobicistat |
cobicistat |
EMEA/H/C/002572 |
Gilead Sciences Ireland UC |
2013/09/19
|
Authorised |
| Incresync |
Human |
alogliptin;pioglitazone |
alogliptin;pioglitazone |
EMEA/H/C/002178 |
Takeda Pharma A/S |
2013/09/19
|
Authorised |
| Trifexis |
Veterinary |
spinosad;milbemycin oxime |
spinosad;milbemycin oxime |
EMEA/V/C/002635 |
Eli Lilly and Company Limited |
2013/09/19
|
Expired |
| Xoterna Breezhaler |
Human |
indacaterol;glycopyrronium bromide |
indacaterol;glycopyrronium bromide |
EMEA/H/C/003755 |
Novartis Europharm Limited |
2013/09/18
|
Authorised |