| Strimvelis |
Human |
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence |
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells |
EMEA/H/C/003854 |
Fondazione Telethon ETS |
2016/05/26
|
Authorised |
| Flixabi |
Human |
infliximab |
infliximab |
EMEA/H/C/004020 |
Samsung Bioepis NL B.V. |
2016/05/26
|
Authorised |
| Palonosetron Accord |
Human |
palonosetron |
palonosetron |
EMEA/H/C/004129 |
Accord Healthcare S.L.U. |
2016/05/26
|
Authorised |
| Neparvis |
Human |
sacubitril;valsartan |
sacubitril;valsartan |
EMEA/H/C/004343 |
Novartis Europharm Limited |
2016/05/26
|
Authorised |
| Galafold |
Human |
migalastat |
migalastat hydrochloride |
EMEA/H/C/004059 |
Amicus Therapeutics Europe Limited |
2016/05/25
|
Authorised |
| Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) |
Human |
pandemic influenza vaccine (H5N1) (live attenuated, nasal) |
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain |
EMEA/H/C/003963 |
AstraZeneca AB |
2016/05/20
|
Authorised |
| Darzalex |
Human |
daratumumab |
daratumumab |
EMEA/H/C/004077 |
Janssen-Cilag International N.V. |
2016/05/20
|
Authorised |
| 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 |