| Segluromet |
Human |
ertugliflozin;metformin hydrochloride |
ertugliflozin l-pyroglutamic acid;metformin hydrochloride |
EMEA/H/C/004314 |
Merck Sharp & Dohme B.V. |
2018/03/23
|
Authorised |
| Alofisel |
Human |
darvadstrocel |
darvadstrocel |
EMEA/H/C/004258 |
Takeda Pharma A/S |
2018/03/23
|
Withdrawn |
| Semglee |
Human |
insulin glargine |
insulin glargine |
EMEA/H/C/004280 |
Biosimilar Collaborations Ireland Limited |
2018/03/23
|
Authorised |
| Lamzede |
Human |
velmanase alfa |
velmanase alfa |
EMEA/H/C/003922 |
Chiesi Farmaceutici S.p.A. |
2018/03/23
|
Authorised |
| Lokelma |
Human |
sodium zirconium cyclosilicate |
sodium zirconium cyclosilicate |
EMEA/H/C/004029 |
AstraZeneca AB |
2018/03/22
|
Authorised |
| Steglatro |
Human |
ertugliflozin |
ertugliflozin l-pyroglutamic acid |
EMEA/H/C/004315 |
Merck Sharp & Dohme B.V. |
2018/03/21
|
Authorised |
| Shingrix |
Human |
herpes zoster vaccine (recombinant, adjuvanted) |
recombinant varicella zoster virus glycoprotein E |
EMEA/H/C/004336 |
GlaxoSmithKline Biologicals S.A. |
2018/03/21
|
Authorised |
| Hemlibra |
Human |
emicizumab |
emicizumab |
EMEA/H/C/004406 |
Roche Registration Limited |
2018/02/23
|
Authorised |
| Crysvita |
Human |
burosumab |
burosumab |
EMEA/H/C/004275 |
Kyowa Kirin Holdings B.V. |
2018/02/19
|
Authorised |
| Anagrelide Viatris (previously Anagrelide Mylan) |
Human |
anagrelide |
anagrelide hydrochloride |
EMEA/H/C/004585 |
Viatris Limited |
2018/02/15
|
Authorised |
| Alkindi |
Human |
hydrocortisone |
hydrocortisone |
EMEA/H/C/004416 |
Neurocrine Netherlands B.V. |
2018/02/09
|
Authorised |
| Herzuma |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/002575 |
Celltrion Healthcare Hungary Kft. |
2018/02/09
|
Authorised |
| Ozempic |
Human |
semaglutide |
semaglutide |
EMEA/H/C/004174 |
Novo Nordisk A/S |
2018/02/08
|
Authorised |
| Efavirenz/Emtricitabine/Tenofovir disoproxil Krka |
Human |
efavirenz;emtricitabine;tenofovir disoproxil |
efavirenz;emtricitabine;tenofovir disoproxil succinate |
EMEA/H/C/004274 |
KRKA, d.d., Novo mesto |
2018/02/08
|
Authorised |
| Darunavir Krka |
Human |
darunavir |
darunavir |
EMEA/H/C/004273 |
KRKA, d.d., Novo mesto |
2018/01/26
|
Authorised |
| Darunavir Krka d.d. |
Human |
darunavir |
darunavir |
EMEA/H/C/004891 |
KRKA, d.d., Novo mesto |
2018/01/18
|
Expired |
| Mvasi |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/004728 |
Amgen Technology (Ireland) UC |
2018/01/15
|
Authorised |
| Ocrevus |
Human |
ocrelizumab |
ocrelizumab |
EMEA/H/C/004043 |
Roche Registration GmbH |
2018/01/08
|
Authorised |
| Prevymis |
Human |
letermovir |
Letermovir |
EMEA/H/C/004536 |
Merck Sharp & Dohme B.V. |
2018/01/08
|
Authorised |
| Adynovi |
Human |
rurioctocog alfa pegol |
rurioctocog alfa pegol |
EMEA/H/C/004195 |
Baxalta Innovations GmbH |
2018/01/08
|
Authorised |