| Doptelet |
Human |
avatrombopag |
avatrombopag maleate |
EMEA/H/C/004722 |
Swedish Orphan Biovitrum AB (publ) |
2019/06/20
|
Authorised |
| Esperoct |
Human |
turoctocog alfa pegol |
turoctocog alfa pegol |
EMEA/H/C/004883 |
Novo Nordisk A/S |
2019/06/20
|
Authorised |
| Trecondi |
Human |
treosulfan |
treosulfan |
EMEA/H/C/004751 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2019/06/20
|
Authorised |
| Sixmo |
Human |
buprenorphine |
buprenorphine hydrochloride |
EMEA/H/C/004743 |
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. |
2019/06/19
|
Withdrawn |
| Temybric Ellipta |
Human |
fluticasone furoate;umeclidinium;vilanterol |
fluticasone furoate;umeclidinium bromide;vilanterol trifenatate |
EMEA/H/C/005254 |
GlaxoSmithKline Trading Services Limited |
2019/06/12
|
Lapsed |
| Zynteglo |
Human |
betibeglogene autotemcel |
autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene |
EMEA/H/C/003691 |
bluebird bio (Netherlands) B.V. |
2019/05/29
|
Withdrawn |
| Frontpro (previously Afoxolaner Merial) |
Veterinary |
afoxolaner |
afoxolaner |
EMEA/V/C/005126 |
|
2019/05/20
|
Authorised |
| Lorviqua |
Human |
lorlatinib |
Lorlatinib |
EMEA/H/C/004646 |
Pfizer Europe MA EEIG |
2019/05/06
|
Authorised |
| Pazenir |
Human |
paclitaxel |
paclitaxel |
EMEA/H/C/004441 |
ratiopharm GmbH |
2019/05/06
|
Authorised |
| Waylivra |
Human |
volanesorsen |
volanesorsen sodium |
EMEA/H/C/004538 |
Akcea Therapeutics Ireland Limited |
2019/05/03
|
Authorised |
| Palynziq |
Human |
pegvaliase |
pegvaliase |
EMEA/H/C/004744 |
BioMarin International Limited |
2019/05/03
|
Authorised |
| Dectova |
Human |
zanamivir |
zanamivir |
EMEA/H/C/004102 |
GlaxoSmithKline Trading Services Limited |
2019/04/26
|
Authorised |
| Skyrizi |
Human |
risankizumab |
risankizumab |
EMEA/H/C/004759 |
AbbVie Deutschland GmbH & Co. KG |
2019/04/26
|
Authorised |
| Ondexxya |
Human |
andexanet alfa |
andexanet alfa |
EMEA/H/C/004108 |
AstraZeneca AB |
2019/04/26
|
Authorised |
| Zynquista |
Human |
sotagliflozin |
sotagliflozin |
EMEA/H/C/004889 |
Guidehouse Germany GmbH |
2019/04/26
|
Withdrawn |
| Idacio |
Human |
adalimumab |
adalimumab |
EMEA/H/C/004475 |
Fresenius Kabi Deutschland GmbH |
2019/04/02
|
Authorised |
| Vizimpro |
Human |
dacomitinib |
dacomitinib monohydrate |
EMEA/H/C/004779 |
Pfizer Europe MA EEIG |
2019/04/02
|
Authorised |
| Kromeya |
Human |
adalimumab |
adalimumab |
EMEA/H/C/005158 |
Fresenius Kabi Deutschland GmbH |
2019/04/02
|
Withdrawn |
| Ajovy |
Human |
fremanezumab |
fremanezumab |
EMEA/H/C/004833 |
Teva GmbH |
2019/03/28
|
Authorised |
| Febuxostat Krka |
Human |
febuxostat |
febuxostat |
EMEA/H/C/004773 |
Krka, d.d., Novo mesto |
2019/03/28
|
Authorised |