| Cinqaero |
Human |
reslizumab |
reslizumab |
EMEA/H/C/003912 |
Teva B.V. |
2016/08/15
|
Authorised |
| Zepatier |
Human |
elbasvir;grazoprevir |
elbasvir;grazoprevir |
EMEA/H/C/004126 |
Merck Sharp & Dohme B.V. |
2016/07/22
|
Authorised |
| Bortezomib Sun |
Human |
bortezomib |
bortezomib |
EMEA/H/C/004076 |
SUN Pharmaceutical Industries (Europe) B.V. |
2016/07/22
|
Authorised |
| Bortezomib Hospira |
Human |
bortezomib |
bortezomib |
EMEA/H/C/004207 |
Pfizer Europe MA EEIG |
2016/07/22
|
Authorised |
| Pemetrexed Fresenius Kabi |
Human |
pemetrexed |
pemetrexed |
EMEA/H/C/003895 |
Fresenius Kabi Deutschland GmbH |
2016/07/22
|
Authorised |
| Qtern |
Human |
saxagliptin;dapagliflozin |
saxagliptin;dapagliflozin propanediol monohydrate |
EMEA/H/C/004057 |
Astra Zeneca AB |
2016/07/15
|
Authorised |
| EndolucinBeta |
Human |
lutetium (177Lu) chloride |
lutetium (177Lu) chloride |
EMEA/H/C/003999 |
ITM Medical Isotopes GmbH |
2016/07/06
|
Authorised |
| Epclusa |
Human |
sofosbuvir;velpatasvir |
sofosbuvir;velpatasvir |
EMEA/H/C/004210 |
Gilead Sciences Ireland UC |
2016/07/06
|
Authorised |
| Zinbryta |
Human |
daclizumab |
daclizumab |
EMEA/H/C/003862 |
Biogen Idec Ltd |
2016/07/01
|
Withdrawn |
| Enzepi |
Human |
pancreas powder |
pancreas powder |
EMEA/H/C/002070 |
Allergan Pharmaceuticals International Limited |
2016/06/29
|
Withdrawn |
| Ongentys |
Human |
opicapone |
opicapone |
EMEA/H/C/002790 |
Bial - Portela Cª, S.A. |
2016/06/24
|
Authorised |
| Zavicefta |
Human |
ceftazidime;avibactam |
avibactam sodium;ceftazidime pentahydrate |
EMEA/H/C/004027 |
Pfizer Ireland Pharmaceuticals Unlimited Company |
2016/06/23
|
Authorised |
| Odefsey |
Human |
emtricitabine;rilpivirine;tenofovir alafenamide |
emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide |
EMEA/H/C/004156 |
Gilead Sciences Ireland UC |
2016/06/21
|
Authorised |
| Neparvis |
Human |
sacubitril;valsartan |
sacubitril;valsartan |
EMEA/H/C/004343 |
Novartis Europharm Limited |
2016/05/26
|
Authorised |
| 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 |
| Galafold |
Human |
migalastat |
migalastat hydrochloride |
EMEA/H/C/004059 |
Amicus Therapeutics Europe Limited |
2016/05/25
|
Authorised |
| Darzalex |
Human |
daratumumab |
daratumumab |
EMEA/H/C/004077 |
Janssen-Cilag International N.V. |
2016/05/20
|
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 |