| 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Withdrawn |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Withdrawn |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Withdrawn |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Withdrawn |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 |
| Vipdomet |
Human |
alogliptin;metformin |
alogliptin benzoate;metformin hydrochloride |
EMEA/H/C/002654 |
Takeda Pharma A/S |
2013/09/18
|
Authorised |
| Vipidia |
Human |
alogliptin benzoate |
alogliptin |
EMEA/H/C/002182 |
Takeda Pharma A/S |
2013/09/18
|
Authorised |
| Lemtrada |
Human |
alemtuzumab |
alemtuzumab |
EMEA/H/C/003718 |
Sanofi Belgium |
2013/09/12
|
Authorised |
| Orphacol |
Human |
cholic acid |
cholic acid |
EMEA/H/C/001250 |
Theravia |
2013/09/12
|
Authorised |
| Remsima |
Human |
infliximab |
infliximab |
EMEA/H/C/002576 |
Celltrion Healthcare Hungary Kft. |
2013/09/10
|
Authorised |
| Inflectra |
Human |
infliximab |
infliximab |
EMEA/H/C/002778 |
Pfizer Europe MA EEIG |
2013/09/10
|
Authorised |
| Provenge |
Human |
autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T) |
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor |
EMEA/H/C/002513 |
Dendreon UK Ltd |
2013/09/06
|
Withdrawn |