| Onbevzi |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005640 |
Samsung Bioepis NL B.V. |
2021/01/11
|
Withdrawn |
| Roclanda |
Human |
latanoprost / netarsudil |
Latanoprost;netarsudil mesilate |
EMEA/H/C/005107 |
Santen Oy |
2021/01/07
|
Authorised |
| Xofluza |
Human |
baloxavir marboxil |
Baloxavir marboxil |
EMEA/H/C/004974 |
Roche Registration GmbH |
2021/01/07
|
Authorised |
| Elzonris |
Human |
tagraxofusp |
tagraxofusp |
EMEA/H/C/005031 |
Stemline Therapeutics B.V. |
2021/01/07
|
Authorised |
| Spikevax (previously COVID-19 Vaccine Moderna) |
Human |
COVID-19 mRNA vaccine |
single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 |
EMEA/H/C/005791 |
Moderna Biotech Spain, S.L. |
2021/01/06
|
Authorised |
| Comirnaty |
Human |
COVID-19 mRNA vaccine |
single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 |
EMEA/H/C/005735 |
BioNTech Manufacturing GmbH |
2020/12/21
|
Authorised |
| Phesgo |
Human |
pertuzumab;trastuzumab |
pertuzumab;trastuzumab |
EMEA/H/C/005386 |
Roche Registration GmbH |
2020/12/21
|
Authorised |
| 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 |
| 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 |
| Libmeldy |
Human |
autologous CD34+ cells encoding ARSA gene |
atidarsagene autotemcel |
EMEA/H/C/005321 |
Orchard Therapeutics (Netherlands) B.V. |
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 |
| Leqvio |
Human |
inclisiran |
inclisiran |
EMEA/H/C/005333 |
Novartis Europharm Limited |
2020/12/09
|
Authorised |
| Trixeo Aerosphere |
Human |
formoterol;glycopyrronium bromide;budesonide |
formoterol fumarate dihydrate;glycopyrronium bromide;Budesonide |
EMEA/H/C/004983 |
AstraZeneca AB |
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 |
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