| Nityr |
Human |
nitisinone |
nitisinone |
EMEA/H/C/004582 |
Cycle Pharmaceuticals (Europe) Ltd |
2018/07/26
|
Authorised |
| Halimatoz |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004866 |
Sandoz GmbH |
2018/07/26
|
Withdrawn |
| Carmustine medac (previously Carmustine Obvius) |
Human |
carmustine |
carmustine |
EMEA/H/C/004326 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2018/07/18
|
Authorised |
| Tegsedi |
Human |
inotersen |
inotersen sodium |
EMEA/H/C/004782 |
Akcea Therapeutics Ireland Limited |
2018/07/06
|
Authorised |
| Verkazia |
Human |
ciclosporin |
ciclosporin |
EMEA/H/C/004411 |
Santen Oy |
2018/07/06
|
Authorised |
| Graspa |
Human |
asparaginase |
asparaginase |
EMEA/H/C/004736 |
ERYTECH Pharma S.A. |
2018/06/27
|
Application withdrawn |
| Dzuveo |
Human |
sufentanil |
sufentanil citrate |
EMEA/H/C/004335 |
Laboratoire Aguettant |
2018/06/25
|
Authorised |
| 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Withdrawn |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 |
Mylan Pharmaceuticals 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Withdrawn |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 |