| Neuraceq |
Human |
florbetaben (18F) |
florbetaben (18F) |
EMEA/H/C/002553 |
Life Molecular Imaging GmbH |
2014/02/20
|
Authorised |
| Mirvaso |
Human |
brimonidine |
brimonidine tartrate |
EMEA/H/C/002642 |
Galderma International |
2014/02/20
|
Authorised |
| Izba |
Human |
travoprost |
travoprost |
EMEA/H/C/002738 |
Novartis Europharm Limited |
2014/02/20
|
Authorised |
| Tecfidera |
Human |
dimethyl fumarate |
|
EMEA/H/C/002601 |
Biogen Netherlands B.V. |
2014/01/30
|
Authorised |
| Xigduo |
Human |
dapagliflozin;metformin |
metformin hydrochloride;dapagliflozin propanediol monohydrate |
EMEA/H/C/002672 |
AstraZeneca AB |
2014/01/16
|
Authorised |
| Tivicay |
Human |
dolutegravir |
dolutegravir |
EMEA/H/C/002753 |
ViiV Healthcare BV |
2014/01/16
|
Authorised |
| Zoledronic Acid Accord |
Human |
zoledronic acid |
zoledronic acid monohydrate |
EMEA/H/C/002667 |
Accord Healthcare S.L.U. |
2014/01/16
|
Authorised |
| Sovaldi |
Human |
sofosbuvir |
sofosbuvir |
EMEA/H/C/002798 |
Gilead Sciences Ireland UC |
2014/01/16
|
Authorised |
| Levetiracetam Hospira |
Human |
levetiracetam |
levetiracetam |
EMEA/H/C/002783 |
Pfizer Europe MA EEIG |
2014/01/07
|
Authorised |
| Opsumit |
Human |
macitentan |
macitentan |
EMEA/H/C/002697 |
Janssen-Cilag International N.V. |
2013/12/20
|
Authorised |
| Brintellix |
Human |
vortioxetine |
vortioxetine |
EMEA/H/C/002717 |
H. Lundbeck A/S |
2013/12/18
|
Authorised |
| Fluenz Tetra |
Human |
influenza vaccine (live attenuated, nasal) |
A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444) |
EMEA/H/C/002617 |
AstraZeneca AB |
2013/12/04
|
Withdrawn |
| Memantine Accord |
Human |
memantine |
memantine hydrochloride |
EMEA/H/C/002766 |
Accord Healthcare S.L.U. |
2013/12/03
|
Authorised |
| Invokana |
Human |
canagliflozin |
canagliflozin |
EMEA/H/C/002649 |
Janssen-Cilag International NV |
2013/11/15
|
Authorised |
| Kadcyla |
Human |
trastuzumab emtansine |
trastuzumab emtansine |
EMEA/H/C/002389 |
Roche Registration GmbH |
2013/11/15
|
Authorised |
| Fortacin |
Human |
lidocaine;prilocaine |
lidocaine;prilocaine |
EMEA/H/C/002693 |
Recordati Ireland Ltd. |
2013/11/15
|
Authorised |
| Abilify Maintena |
Human |
aripiprazole |
aripiprazole |
EMEA/H/C/002755 |
Otsuka Pharmaceutical Netherlands B.V. |
2013/11/14
|
Authorised |
| Xofigo |
Human |
radium Ra223 dichloride |
radium (223Ra) dichloride |
EMEA/H/C/002653 |
Bayer AG |
2013/11/13
|
Authorised |
| Relvar Ellipta |
Human |
fluticasone furoate;vilanterol |
fluticasone furoate;vilanterol |
EMEA/H/C/002673 |
GlaxoSmithKline Trading Services Limited |
2013/11/13
|
Authorised |
| NovoEight |
Human |
turoctocog alfa |
turoctocog alfa |
EMEA/H/C/002719 |
Novo Nordisk A/S |
2013/11/13
|
Authorised |