| Uptravi |
Human |
selexipag |
selexipag |
EMEA/H/C/003774 |
Janssen Cilag International NV |
2016/05/12
|
Authorised |
| Alprolix |
Human |
eftrenonacog alfa |
eftrenonacog alfa |
EMEA/H/C/004142 |
Swedish Orphan Biovitrum AB (publ) |
2016/05/12
|
Authorised |
| Empliciti |
Human |
elotuzumab |
Elotuzumab |
EMEA/H/C/003967 |
Bristol-Myers Squibb Pharma EEIG |
2016/05/11
|
Authorised |
| Idelvion |
Human |
albutrepenonacog alfa |
albutrepenonacog alfa |
EMEA/H/C/003955 |
CSL Behring GmbH |
2016/05/11
|
Authorised |
| Taltz |
Human |
ixekizumab |
ixekizumab |
EMEA/H/C/003943 |
Eli Lilly and Company (Ireland) Limited |
2016/04/25
|
Authorised |
| Lonsurf |
Human |
trifluridine;tipiracil |
trifluridine;tipiracil hydrochloride |
EMEA/H/C/003897 |
Les Laboratoires Servier |
2016/04/25
|
Authorised |
| Descovy |
Human |
emtricitabine;tenofovir alafenamide |
emtricitabine;tenofovir alafenamide |
EMEA/H/C/004094 |
Gilead Sciences Ireland UC |
2016/04/21
|
Authorised |
| Palonosetron Hospira |
Human |
palonosetron |
palonosetron hydrochloride |
EMEA/H/C/004069 |
Pfizer Europe MA EEIG |
2016/04/08
|
Withdrawn |
| Rasagiline Viatris (previously Rasagiline Mylan) |
Human |
rasagiline |
rasagiline tartrate |
EMEA/H/C/004064 |
Viatris Limited |
2016/04/04
|
Authorised |
| Zonisamide Viatris (previously Zonisamide Mylan) |
Human |
zonisamide |
zonisamide |
EMEA/H/C/004127 |
Viatris Limited |
2016/03/31
|
Authorised |
| Wakix |
Human |
pitolisant |
pitolisant |
EMEA/H/C/002616 |
Bioprojet Pharma |
2016/03/31
|
Authorised |
| Amlodipine / Valsartan Mylan |
Human |
amlodipine;valsartan |
amlodipine besilate;valsartan |
EMEA/H/C/004037 |
Mylan Pharmaceuticals Limited |
2016/03/22
|
Authorised |
| Coagadex |
Human |
human coagulation factor X |
human coagulation factor X |
EMEA/H/C/003855 |
Kedrion S.p.A. |
2016/03/16
|
Authorised |
| Neofordex |
Human |
dexamethasone |
dexamethasone |
EMEA/H/C/004071 |
THERAVIA |
2016/03/16
|
Authorised |
| Kovaltry |
Human |
octocog alfa |
octocog alfa |
EMEA/H/C/003825 |
Bayer AG |
2016/02/18
|
Authorised |
| Feraccru |
Human |
ferric maltol |
ferric maltol |
EMEA/H/C/002733 |
Norgine B.V. |
2016/02/18
|
Authorised |
| Zurampic |
Human |
lesinurad |
lesinurad |
EMEA/H/C/003932 |
Grünenthal GmbH |
2016/02/18
|
Withdrawn |
| Iblias |
Human |
octocog alfa |
octocog alfa |
EMEA/H/C/004147 |
Bayer AG |
2016/02/18
|
Withdrawn |
| Vaxelis |
Human |
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed) |
Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3;hepatitis B surface antigen produced in yeast cells;poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. |
EMEA/H/C/003982 |
MCM Vaccine B.V. |
2016/02/15
|
Authorised |
| Portrazza |
Human |
necitumumab |
necitumumab |
EMEA/H/C/003886 |
Eli Lilly Nederland B.V. |
2016/02/15
|
Withdrawn |