| Onpattro |
Human |
patisiran |
patisiran sodium |
EMEA/H/C/004699 |
Alnylam Netherlands B.V. |
2018/08/27
|
Authorised |
| Ulipristal Acetate Gedeon Richter |
Human |
ulipristal acetate |
ulipristal acetate |
EMEA/H/C/005017 |
Gedeon Richter Plc. |
2018/08/27
|
Withdrawn |
| Yescarta |
Human |
axicabtagene ciloleucel |
axicabtagene ciloleucel |
EMEA/H/C/004480 |
Kite Pharma EU B.V. |
2018/08/23
|
Authorised |
| Kymriah |
Human |
tisagenlecleucel |
tisagenlecleucel |
EMEA/H/C/004090 |
Novartis Europharm Limited |
2018/08/23
|
Authorised |
| Mepsevii |
Human |
vestronidase alfa |
vestronidase alfa |
EMEA/H/C/004438 |
Ultragenyx Germany GmbH |
2018/08/23
|
Authorised |
| Vyxeos liposomal (previously Vyxeos) |
Human |
daunorubicin;cytarabine |
daunorubicin hydrochloride;cytarabine |
EMEA/H/C/004282 |
Jazz Pharmaceuticals Ireland Limited |
2018/08/23
|
Authorised |
| Duzallo |
Human |
allopurinol;lesinurad |
allopurinol;lesinurad |
EMEA/H/C/004412 |
Grunenthal GmbH |
2018/08/23
|
Withdrawn |
| Myalepta |
Human |
metreleptin |
Metreleptin |
EMEA/H/C/004218 |
Chiesi Farmaceutici S.p.A. |
2018/07/30
|
Authorised |
| Trazimera |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/004463 |
Pfizer Europe MA EEIG |
2018/07/26
|
Authorised |
| Hyrimoz |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004320 |
Sandoz GmbH |
2018/07/26
|
Authorised |
| Hefiya |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004865 |
Sandoz GmbH |
2018/07/26
|
Authorised |
| Aimovig |
Human |
erenumab |
erenumab |
EMEA/H/C/004447 |
Novartis Europharm Limited |
2018/07/26
|
Authorised |
| Rxulti |
Human |
brexpiprazole |
brexpiprazole |
EMEA/H/C/003841 |
Otsuka Pharmaceutical Netherlands B.V. |
2018/07/26
|
Authorised |
| 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Withdrawn |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 |
| Verkazia |
Human |
ciclosporin |
ciclosporin |
EMEA/H/C/004411 |
Santen Oy |
2018/07/06
|
Authorised |
| Tegsedi |
Human |
inotersen |
inotersen sodium |
EMEA/H/C/004782 |
Akcea Therapeutics Ireland Limited |
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Application withdrawn |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 |