| Braftovi |
Human |
encorafenib |
Encorafenib |
EMEA/H/C/004580 |
Pierre Fabre Medicament |
2018/09/19
|
Authorised |
| Deferiprone Lipomed |
Human |
deferiprone |
Deferiprone |
EMEA/H/C/004710 |
Lipomed GmbH |
2018/09/19
|
Authorised |
| Ilumetri |
Human |
tildrakizumab |
tildrakizumab |
EMEA/H/C/004514 |
Almirall, S.A. |
2018/09/17
|
Authorised |
| Hulio |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004429 |
Biosimilar Collaborations Ireland Limited |
2018/09/17
|
Authorised |
| Veyvondi |
Human |
vonicog alfa |
vonicog alfa |
EMEA/H/C/004454 |
Baxalta Innovations GmbH |
2018/08/31
|
Authorised |
| Nerlynx |
Human |
neratinib |
neratinib |
EMEA/H/C/004030 |
Pierre Fabre Medicament |
2018/08/31
|
Authorised |
| Cablivi |
Human |
caplacizumab |
Caplacizumab |
EMEA/H/C/004426 |
Ablynx NV |
2018/08/30
|
Authorised |
| 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Withdrawn |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Withdrawn |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 |
| 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 |
| Trazimera |
Human |
trastuzumab |
trastuzumab |
EMEA/H/C/004463 |
Pfizer Europe MA EEIG |
2018/07/26
|
Authorised |