| Trevicta (previously Paliperidone Janssen) |
Human |
paliperidone |
paliperidone palmitate |
EMEA/H/C/004066 |
Janssen-Cilag International NV |
2014/12/05
|
Authorised |
| Trulicity |
Human |
dulaglutide |
dulaglutide |
EMEA/H/C/002825 |
Eli Lilly Nederland B.V. |
2014/11/21
|
Authorised |
| Tadalafil Mylan |
Human |
tadalafil |
tadalafil |
EMEA/H/C/003787 |
Mylan Pharmaceuticals Limited |
2014/11/21
|
Authorised |
| Vargatef |
Human |
nintedanib |
nintedanib |
EMEA/H/C/002569 |
Boehringer Ingelheim International GmbH |
2014/11/21
|
Authorised |
| Rezolsta |
Human |
darunavir;cobicistat |
darunavir;cobicistat |
EMEA/H/C/002819 |
Janssen-Cilag International N.V. |
2014/11/19
|
Authorised |
| Duaklir Genuair |
Human |
aclidinium bromide;formoterol |
aclidinium bromide;formoterol fumarate dihydrate |
EMEA/H/C/003745 |
Covis Pharma Europe B.V. |
2014/11/19
|
Authorised |
| Brimica Genuair |
Human |
aclidinium;formoterol fumarate dihydrate |
formoterol fumarate dihydrate;aclidinium bromide |
EMEA/H/C/003969 |
Covis Pharma Europe B.V. |
2014/11/19
|
Authorised |
| Lymphoseek |
Human |
tilmanocept |
tilmanocept |
EMEA/H/C/002085 |
Navidea Biopharmaceuticals Europe Ltd. |
2014/11/19
|
Withdrawn |
| Budesonide/Formoterol Teva |
Human |
budesonide;formoterol |
Budesonide;formoterol fumarate dihydrate |
EMEA/H/C/003951 |
Teva Pharma B.V. |
2014/11/19
|
Withdrawn |
| Budesonide/Formoterol Teva Pharma B.V. |
Human |
budesonide;formoterol fumarate dihydrate |
Budesonide;formoterol |
EMEA/H/C/003953 |
Teva Pharma B.V. |
2014/11/19
|
Withdrawn |
| Vylaer Spiromax |
Human |
budesonide;formoterol |
Budesonide;formoterol fumarate dihydrate |
EMEA/H/C/003952 |
Teva Pharma B.V. |
2014/11/19
|
Withdrawn |
| Ketoconazole Esteve (previously Ketoconazole HRA) |
Human |
ketoconazole |
Ketoconazole |
EMEA/H/C/003906 |
Esteve Pharmaceuticals, S.A. |
2014/11/18
|
Authorised |
| Harvoni |
Human |
ledispavir;sofosbuvir |
ledipasvir;sofosbuvir |
EMEA/H/C/003850 |
Gilead Sciences Ireland UC |
2014/11/17
|
Authorised |
| Imbruvica |
Human |
ibrutinib |
Ibrutinib |
EMEA/H/C/003791 |
Janssen-Cilag International NV |
2014/10/21
|
Authorised |
| Busulfan Fresenius Kabi |
Human |
busulfan |
busulfan |
EMEA/H/C/002806 |
Fresenius Kabi Deutschland GmbH |
2014/09/22
|
Authorised |
| Xultophy |
Human |
insulin degludec;liraglutide |
insulin degludec;liraglutide |
EMEA/H/C/002647 |
Novo Nordisk A/S |
2014/09/18
|
Authorised |
| Zydelig |
Human |
idelalisib |
Idelalisib |
EMEA/H/C/003843 |
Gilead Sciences Ireland UC |
2014/09/18
|
Authorised |
| Accofil |
Human |
filgrastim |
filgrastim |
EMEA/H/C/003956 |
Accord Healthcare S.L.U. |
2014/09/17
|
Authorised |
| Abasaglar (previously Abasria) |
Human |
insulin glargine |
insulin glargine |
EMEA/H/C/002835 |
Eli Lilly Nederland B.V. |
2014/09/09
|
Authorised |
| Clopidogrel/Acetylsalicylic acid Teva |
Human |
clopidogrel;acetylsalicylic acid |
clopidogrel;acetylsalicylic acid |
EMEA/H/C/002272 |
Teva Pharma B.V. |
2014/09/01
|
Withdrawn |