Fareston |
Human |
toremifene |
toremifene |
EMEA/H/C/000091 |
Orion Corporation |
1996/02/14
|
Authorised |
CellCept |
Human |
mycophenolate mofetil |
mycophenolate mofetil |
EMEA/H/C/000082 |
Roche Registration GmbH |
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 |
Nobivac L4 |
Veterinary |
Vaccine to prevent Leptospira infections in dogs |
Leptospira interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000);L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001);L. interrogans serogroup Australis serovar Bratislava (strain As-05-073);L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005) |
EMEA/V/C/002010 |
|
|
Authorised |
Versican Plus DHPPi |
Veterinary |
canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus |
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated) |
EMEA/V/C/003679 |
|
|
Authorised |
Versican Plus DHPPi/L4 |
Veterinary |
live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated |
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091... |
EMEA/V/C/003678 |
|
|
Authorised |
Purevax RCP FeLV |
Veterinary |
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia |
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain);inactivated feline calicivirosis antigens (FCV 431 and G1 strains);attenuated feline panleucopenia virus (PLI IV);FeLV recombinant canarypox virus (vCP97) |
EMEA/V/C/000089 |
|
|
Authorised |
Purevax RCP |
Veterinary |
vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia |
attenuated feline panleucopenia virus (PLI IV) |
EMEA/V/C/000090 |
|
|
Authorised |
Purevax FeLV |
Veterinary |
vaccine against feline leukaemia |
feline leukaemia virus recombinant canarypox virus (vCP97) |
EMEA/V/C/000056 |
|
|
Authorised |
Epixram |
Human |
levetiracetam |
|
EMEA/H/C/006186 |
Neuraxpharm Pharmaceuticals S.L. |
|
Application withdrawn |
Durysta |
Human |
bimatoprost |
bimatoprost |
EMEA/H/C/005916 |
AbbVie Deutschland GmbH & Co. KG |
|
Application withdrawn |
Kizfizo |
Human |
temozolomide |
temozolomide |
EMEA/H/C/006169 |
ORPHELIA Pharma |
|
Opinion |
Bamlanivimab and etesevimab for COVID-19 |
Human |
|
Bamlanivimab;Etesevimab |
EMEA/H/C/005836 |
Eli Lilly Nederland B.V. |
|
Withdrawn from rolling review |
Stoboclo |
Human |
denosumab |
denosumab |
EMEA/H/C/006156 |
Celltrion Healthcare Hungary Kft. |
|
Opinion |
Andembry |
Human |
garadacimab |
garadacimab |
EMEA/H/C/006116 |
CSL Behring GmbH |
|
Opinion |
Avtozma |
Human |
tocilizumab |
tocilizumab |
EMEA/H/C/006196 |
Celltrion Healthcare Hungary Kft. |
|
Opinion |
Beyonttra |
Human |
acoramidis |
acoramidis hydrochloride |
EMEA/H/C/006333 |
BridgeBio Europe B.V. |
|
Opinion |
Emcitate |
Human |
tiratricol |
tiratricol |
EMEA/H/C/005220 |
Rare Thyroid Therapeutics International AB |
|
Opinion |