| Fintepla |
Human |
fenfluramine |
fenfluramine hydrochloride |
EMEA/H/C/003933 |
UCB Pharma S.A. |
2020/12/18
|
Authorised |
| Lenalidomide Mylan |
Human |
lenalidomide |
lenalidomide |
EMEA/H/C/005306 |
Mylan Ireland Limited |
2020/12/18
|
Authorised |
| Libmeldy |
Human |
autologous CD34+ cells encoding ARSA gene |
atidarsagene autotemcel |
EMEA/H/C/005321 |
Orchard Therapeutics (Netherlands) B.V. |
2020/12/17
|
Authorised |
| Palforzia |
Human |
defatted powder of Arachis hypogaea L., semen (peanuts) |
defatted powder of Arachis hypogaea L., semen (peanuts) |
EMEA/H/C/004917 |
Stallergenes |
2020/12/17
|
Authorised |
| Rekambys |
Human |
rilpivirine |
rilpivirine |
EMEA/H/C/005060 |
Janssen-Cilag International NV |
2020/12/17
|
Authorised |
| Vocabria |
Human |
cabotegravir |
cabotegavir sodium;cabotegravir |
EMEA/H/C/004976 |
ViiV Healthcare B.V. |
2020/12/17
|
Authorised |
| Tecartus |
Human |
brexucabtagene autoleucel |
autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) |
EMEA/H/C/005102 |
Kite Pharma EU B.V. |
2020/12/14
|
Authorised |
| Trixeo Aerosphere |
Human |
formoterol;glycopyrronium bromide;budesonide |
formoterol fumarate dihydrate;glycopyrronium bromide;Budesonide |
EMEA/H/C/004983 |
AstraZeneca AB |
2020/12/09
|
Authorised |
| Leqvio |
Human |
inclisiran |
inclisiran |
EMEA/H/C/005333 |
Novartis Europharm Limited |
2020/12/09
|
Authorised |
| Oxlumo |
Human |
lumasiran |
Lumasiran sodium |
EMEA/H/C/005040 |
Alnylam Netherlands B.V. |
2020/11/19
|
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 |
| Nyvepria |
Human |
pegfilgrastim |
pegfilgrastim |
EMEA/H/C/005085 |
Pfizer Europe MA EEIG |
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Withdrawn |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 |