| Oxlumo |
Human |
lumasiran |
Lumasiran sodium |
EMEA/H/C/005040 |
Alnylam Netherlands B.V. |
2020/11/19
|
Authorised |
| Nyvepria |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/005085 |
Pfizer Europe MA EEIG |
2020/11/18
|
Authorised |
| MenQuadfi |
Human |
meningococcal group A, C, W-135 and Y conjugate vaccine |
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid |
EMEA/H/C/005084 |
Sanofi Winthrop Industrie |
2020/11/18
|
Authorised |
| Nyxthracis (previously Obiltoxaximab SFL) |
Human |
obiltoxaximab |
nyxthracis |
EMEA/H/C/005169 |
SFL Pharmaceuticals Deutschland GmbH |
2020/11/18
|
Withdrawn |
| Rivaroxaban Accord |
Human |
rivaroxaban |
rivaroxaban |
EMEA/H/C/005279 |
Accord Healthcare S.L.U. |
2020/11/16
|
Authorised |
| Exparel liposomal |
Human |
bupivacaine |
bupivacaine |
EMEA/H/C/004586 |
Pacira Ireland Limited |
2020/11/16
|
Authorised |
| Supemtek Tetra (previously Supemtek) |
Human |
quadrivalent influenza vaccine (recombinant, prepared in cell culture) |
Influenza A virus subtype H1N1 haemagglutinin, recombinant;Influenza A virus subtype H3N2 haemagglutinin, recombinant;Influenza B virus Victoria lineage haemagglutinin, recombinant;Influenza B virus Yamagata lineage haemagglutinin, recombinant |
EMEA/H/C/005159 |
Sanofi Winthrop Industrie |
2020/11/16
|
Authorised |
| Phelinun |
Human |
melphalan |
melphalan hydrochloride |
EMEA/H/C/005173 |
ADIENNE S.r.l. S.U. |
2020/11/16
|
Authorised |
| Calquence |
Human |
acalabrutinib |
acalabrutinib;acalabrutinib maleate |
EMEA/H/C/005299 |
AstraZeneca AB |
2020/11/05
|
Authorised |
| Adakveo |
Human |
crizanlizumab |
Crizanlizumab |
EMEA/H/C/004874 |
Novartis Europharm Limited |
2020/10/28
|
Revoked |
| Arikayce liposomal |
Human |
amikacin |
amikacin sulfate |
EMEA/H/C/005264 |
Insmed Netherlands B.V. |
2020/10/27
|
Authorised |
| Ayvakyt |
Human |
avapritinib |
avapritinib |
EMEA/H/C/005208 |
Blueprint Medicines (Netherlands) B.V. |
2020/09/24
|
Authorised |
| Fampridine Accord |
Human |
fampridine |
Fampridine |
EMEA/H/C/005359 |
Accord Healthcare S.L.U. |
2020/09/24
|
Authorised |
| Jyseleca |
Human |
filgotinib |
filgotinib maleate |
EMEA/H/C/005113 |
Alfasigma S.p.A. |
2020/09/24
|
Authorised |
| Zynrelef |
Human |
bupivacaine;meloxicam |
bupivacaine;meloxicam |
EMEA/H/C/005205 |
Heron Therapeutics, B.V. |
2020/09/24
|
Withdrawn |
| Equidacent |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005181 |
Centus Biotherapeutics Europe Limited |
2020/09/24
|
Withdrawn |
| Arsenic trioxide medac |
Human |
arsenic trioxide |
arsenic trioxide |
EMEA/H/C/005218 |
medac Gesellschaft für klinische Spezialpräparate mbH |
2020/09/17
|
Authorised |
| Cabazitaxel Accord |
Human |
cabazitaxel |
cabazitaxel |
EMEA/H/C/005178 |
Accord Healthcare S.L.U. |
2020/08/28
|
Authorised |
| Livogiva |
Human |
teriparatide |
teriparatide |
EMEA/H/C/005087 |
Theramex Ireland Limited |
2020/08/27
|
Authorised |
| Qutavina |
Human |
teriparatide |
teriparatide |
EMEA/H/C/005388 |
EuroGenerics Holdings B.V. |
2020/08/27
|
Withdrawn |
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