| Humalog |
Human |
insulin lispro |
insulin lispro |
EMEA/H/C/000088 |
Eli Lilly Nederland B.V. |
1996/04/30
|
Authorised |
| NovoSeven |
Human |
eptacog alfa (activated) |
eptacog alfa (activated) |
EMEA/H/C/000074 |
Novo Nordisk A/S |
1996/02/23
|
Authorised |
| CellCept |
Human |
mycophenolate mofetil |
mycophenolate mofetil |
EMEA/H/C/000082 |
Roche Registration GmbH |
1996/02/14
|
Authorised |
| Fareston |
Human |
toremifene |
toremifene |
EMEA/H/C/000091 |
Orion Corporation |
1996/02/14
|
Authorised |
| Betaferon |
Human |
interferon beta-1b |
interferon beta-1b |
EMEA/H/C/000081 |
Bayer AG |
1995/11/30
|
Authorised |
| Taxotere |
Human |
docetaxel |
docetaxel |
EMEA/H/C/000073 |
Sanofi Winthrop Industrie |
1995/11/27
|
Authorised |
| GONAL-f |
Human |
follitropin alfa |
follitropin alfa |
EMEA/H/C/000071 |
Merck Europe B.V. |
1995/10/20
|
Authorised |
| Tolvaptan Accord |
Human |
tolvaptan |
tolvaptan |
EMEA/H/C/005961 |
Accord Healthcare S.L.U. |
|
Authorised |
| Nurzigma |
Human |
pridopidine |
pridopidine hydrochloride |
EMEA/H/C/006261 |
Prilenia Therapeutics B.V. |
|
Application withdrawn |
| Ecovaxxin MS |
Veterinary |
Mycoplasma synoviae, strain K588A, Live |
Mycoplasma synoviae, strain K588A, Live |
EMEA/V/C/006604 |
|
|
Authorised |
| Vaxxinact H5 |
Veterinary |
Avian influenza virus, subtype H5, haemagglutinin (recombinant) |
Avian influenza virus, subtype H5, haemagglutinin (recombinant) |
EMEA/V/C/006717 |
|
|
Authorised |
| Blarcamesine Anavex |
Human |
blarcamesine |
blarcamesine hydrochloride |
EMEA/H/C/006475 |
|
|
Opinion under re-examination |
| Omforro |
Human |
midazolam |
Midazolam Hydrochloride |
EMEA/H/C/005657 |
Regulatory Pharma Net S.r.l. |
|
Application withdrawn |
| mNexspike |
Human |
COVID-19 mRNA vaccine |
mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283) |
EMEA/H/C/006428 |
Moderna Biotech Spain, S.L. |
|
Opinion |
| Jelrix |
Human |
autologous cartilage-derived articular chondrocytes, in-vitro expanded |
|
EMEA/H/C/004594 |
TETEC Tissue Engineering Technologies AG |
|
Application withdrawn |
| Anktiva |
Human |
nogapendekin alfa inbakicept |
nogapendekin alfa inbakicept |
EMEA/H/C/006622 |
Serum Life Science Europe GmbH |
|
Opinion |
| Aumseqa |
Human |
Aumolertinib |
Aumolertinib mesilate |
EMEA/H/C/006069 |
SFL Pharmaceuticals Deutschland GmbH |
|
Opinion |
| Exdensur |
Human |
depemokimab |
depemokimab |
EMEA/H/C/006446 |
GlaxoSmithKline Trading Services Limited |
|
Opinion |
| Gotenfia |
Human |
golimumab |
golimumab |
EMEA/H/C/006621 |
Stada Arzneimittel AG |
|
Opinion |
| Ranluspec |
Human |
ranibizumab |
ranibizumab |
EMEA/H/C/006502 |
Lupin Europe GmbH |
|
Opinion |