| Biktarvy |
Human |
bictegravir;emtricitabine;tenofovir alafenamide |
bictegravir;emtricitabine;tenofovir alafenamide;fumarate |
EMEA/H/C/004449 |
Gilead Sciences Ireland UC |
2018/06/21
|
Authorised |
| Amglidia |
Human |
glibenclamide |
glibenclamide |
EMEA/H/C/004379 |
Ammtek |
2018/05/24
|
Authorised |
| Rubraca |
Human |
rucaparib |
Rucaparib camsylate |
EMEA/H/C/004272 |
pharmaand GmbH |
2018/05/23
|
Authorised |
| Pemetrexed Krka |
Human |
pemetrexed |
pemetrexed disodium |
EMEA/H/C/003958 |
KRKA d.d. |
2018/05/22
|
Withdrawn |
| Zessly |
Human |
infliximab |
infliximab |
EMEA/H/C/004647 |
Sandoz GmbH |
2018/05/18
|
Authorised |
| Juluca |
Human |
dolutegravir;rilpivirine |
dolutegravir sodium;rilpivirine hydrochloride |
EMEA/H/C/004427 |
ViiV Healthcare B.V. |
2018/05/16
|
Authorised |
| Kanjinti |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/004361 |
Amgen Europe B.V. |
2018/05/16
|
Authorised |
| Prasugrel Viatris (previously Prasugrel Mylan) |
Human |
prasugrel |
prasugrel besilate |
EMEA/H/C/004644 |
Viatris Limited |
2018/05/15
|
Authorised |
| Trydonis |
Human |
beclometasone;formoterol;glycopyrronium bromide |
beclometasone dipropionate;formoterol fumarate dihydrate;glycopyrronium |
EMEA/H/C/004702 |
Chiesi Farmaceutici S.p.A. |
2018/04/26
|
Authorised |
| Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) |
Human |
beclometasone;formoterol |
formoterol fumarate dihydrate;glycopyrronium;beclometasone dipropionate |
EMEA/H/C/004836 |
Chiesi Farmaceutici S.p.A. |
2018/04/23
|
Withdrawn |
| Mylotarg |
Human |
gemtuzumab ozogamicin |
gemtuzumab ozogamicin |
EMEA/H/C/004204 |
Pfizer Europe MA EEIG |
2018/04/19
|
Authorised |
| Alpivab |
Human |
peramivir |
peramivir |
EMEA/H/C/004299 |
Biocryst |
2018/04/13
|
Withdrawn |
| Steglujan |
Human |
ertugliflozin;sitagliptin |
ertugliflozin l-pyroglutamic acid;sitagliptin phosphate monohydrate |
EMEA/H/C/004313 |
Merck Sharp & Dohme B.V. |
2018/03/23
|
Authorised |
| 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Withdrawn |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 |
| 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 |
| Steglatro |
Human |
ertugliflozin |
ertugliflozin l-pyroglutamic acid |
EMEA/H/C/004315 |
Merck Sharp & Dohme B.V. |
2018/03/21
|
Authorised |