| Fulvestrant Mylan |
Human |
fulvestrant |
fulvestrant |
EMEA/H/C/004649 |
Mylan Pharmaceuticals Limited |
2018/01/08
|
Authorised |
| Fasenra |
Human |
benralizumab |
Benralizumab |
EMEA/H/C/004433 |
AstraZeneca AB |
2018/01/08
|
Authorised |
| Intrarosa |
Human |
prasterone |
prasterone |
EMEA/H/C/004138 |
Endoceutics S.A. |
2018/01/08
|
Authorised |
| Jorveza |
Human |
budesonide |
Budesonide |
EMEA/H/C/004655 |
Dr. Falk Pharma GmbH |
2018/01/08
|
Authorised |
| Tacforius |
Human |
tacrolimus |
tacrolimus monohydrate |
EMEA/H/C/004435 |
Teva B.V. |
2017/12/08
|
Authorised |
| Zejula |
Human |
niraparib |
niraparib (tosilate monohydrate) |
EMEA/H/C/004249 |
GlaxoSmithKline Trading Services Limited |
2017/11/16
|
Authorised |
| Elebrato Ellipta |
Human |
fluticasone furoate;umeclidinium;vilanterol |
fluticasone furoate;umeclidinium bromide;vilanterol trifenatate |
EMEA/H/C/004781 |
GlaxoSmithKline Trading Services Limited |
2017/11/15
|
Authorised |
| Trelegy Ellipta |
Human |
fluticasone furoate;umeclidinium;vilanterol |
fluticasone furoate;umeclidinium bromide;vilanterol trifenatate |
EMEA/H/C/004363 |
GlaxoSmithKline Trading Services Limited |
2017/11/15
|
Authorised |
| Ontruzant |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/004323 |
Samsung Bioepis NL B.V. |
2017/11/15
|
Authorised |
| Imatinib Teva B.V. |
Human |
imatinib |
imatinib mesilate |
EMEA/H/C/004748 |
Teva B.V. |
2017/11/15
|
Withdrawn |
| Zubsolv |
Human |
buprenorphine;naloxone |
buprenorphine hydrochloride;naloxone hydrochloride dihydrate |
EMEA/H/C/004407 |
Accord Healthcare S.L.U. |
2017/11/10
|
Authorised |
| Tremfya |
Human |
guselkumab |
Guselkumab |
EMEA/H/C/004271 |
Janssen-Cilag International NV |
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Withdrawn |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 |