| Zubsolv |
Human |
buprenorphine;naloxone |
buprenorphine hydrochloride;naloxone hydrochloride dihydrate |
EMEA/H/C/004407 |
Accord Healthcare S.L.U. |
2017/11/10
|
Authorised |
| VeraSeal |
Human |
human fibrinogen;human thrombin |
human fibrinogen, human thrombin |
EMEA/H/C/004446 |
Instituto Grifols, S.A. |
2017/11/10
|
Authorised |
| Tookad |
Human |
padeliporfin |
padeliporfin di-potassium |
EMEA/H/C/004182 |
STEBA Biotech S.A |
2017/11/10
|
Authorised |
| Cyltezo |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004319 |
Boehringer Ingelheim International GmbH |
2017/11/10
|
Withdrawn |
| Ritonavir Viatris (previously Ritonavir Mylan) |
Human |
ritonavir |
ritonavir |
EMEA/H/C/004549 |
Viatris Limited |
2017/11/09
|
Authorised |
| Miglustat Gen.Orph |
Human |
miglustat |
miglustat |
EMEA/H/C/004366 |
Gen.Orph |
2017/11/09
|
Authorised |
| Nyxoid |
Human |
naloxone |
naloxone hydrochloride dihydrate |
EMEA/H/C/004325 |
Mundipharma Corporation (Ireland) Limited |
2017/11/09
|
Authorised |
| Dupixent |
Human |
dupilumab |
dupilumab |
EMEA/H/C/004390 |
Sanofi Winthrop Industrie |
2017/09/26
|
Authorised |
| Lutathera |
Human |
lutetium (177Lu) oxodotreotide |
lutetium (177Lu) oxodotreotide |
EMEA/H/C/004123 |
Advanced Accelerator Applications |
2017/09/26
|
Authorised |
| Entecavir Accord |
Human |
entecavir |
Entecavir |
EMEA/H/C/004458 |
Accord Healthcare S.L.U. |
2017/09/25
|
Authorised |
| Symtuza |
Human |
darunavir;cobicistat;emtricitabine;tenofovir alafenamide |
darunavir;cobicistat;emtricitabine;tenofovir alafenamide |
EMEA/H/C/004391 |
Janssen-Cilag International NV |
2017/09/21
|
Authorised |
| Tecentriq |
Human |
atezolizumab |
atezolizumab |
EMEA/H/C/004143 |
Roche Registration GmbH |
2017/09/20
|
Authorised |
| Bavencio |
Human |
avelumab |
avelumab |
EMEA/H/C/004338 |
Merck Europe B.V. |
2017/09/18
|
Authorised |
| Entecavir Viatris (previously Entecavir Mylan) |
Human |
entecavir |
entecavir monohydrate |
EMEA/H/C/004377 |
Viatris Limited |
2017/09/18
|
Authorised |
| Rydapt |
Human |
midostaurin |
Midostaurin |
EMEA/H/C/004095 |
Novartis Europharm Ltd |
2017/09/18
|
Authorised |
| Lacosamide Accord |
Human |
lacosamide |
lacosamide |
EMEA/H/C/004443 |
Accord Healthcare S.L.U. |
2017/09/18
|
Authorised |
| Xermelo |
Human |
telotristat ethyl |
telotristat etiprate |
EMEA/H/C/003937 |
SERB SAS |
2017/09/17
|
Authorised |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Human |
efavirenz;emtricitabine;tenofovir disoproxil |
efavirenz;emtricitabine;tenofovir disoproxil maleate |
EMEA/H/C/004240 |
Mylan Pharmaceuticals Limited |
2017/09/05
|
Authorised |
| Cuprior |
Human |
trientine |
trientine tetrahydrochloride |
EMEA/H/C/004005 |
Orphalan |
2017/09/05
|
Authorised |
| Imraldi |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004279 |
Samsung Bioepis NL B.V. |
2017/08/24
|
Authorised |