Elelyso |
Human |
taliglucerase alfa |
Taliglucerase alfa |
EMEA/H/C/002250 |
Pfizer Ltd. |
|
Refused |
Folotyn |
Human |
pralatrexate |
Pralatrexate |
EMEA/H/C/002096 |
Allos Therapeutics Ltd |
|
Refused |
Gamifant |
Human |
emapalumab |
Emapalumab |
EMEA/H/C/004386 |
Swedish Orphan Biovitrum AB (publ) |
|
Refused |
Lextemy |
Human |
bevacizumab |
bevacizumab |
EMEA/H/C/005611 |
Mylan IRE Healthcare Limited |
|
Withdrawn |
Exondys |
Human |
eteplirsen |
eteplirsen |
EMEA/H/C/004355 |
AVI Biopharma International Ltd |
|
Refused |
Dexxience |
Human |
betrixaban |
betrixaban maleate |
EMEA/H/C/004309 |
Portola Pharma UK Limited |
|
Refused |
Alsitek |
Human |
masitinib |
Masitinib mesilate |
EMEA/H/C/004398 |
AB Science |
|
Refused |
Sumatriptan Galpharm |
Human |
sumatriptan |
sumatriptan succinate |
EMEA/H/C/002140 |
Galpharm Healthcare Ltd. |
|
Refused |
Xeljanz |
Human |
tofacitinib |
Tofacitinib |
EMEA/H/C/002542 |
Pfizer Limited |
|
Refused |
Masipro |
Human |
masitinib |
Masitinib mesilate |
EMEA/H/C/004159 |
AB Science |
|
Refused |
Fanaptum |
Human |
iloperidone |
iloperidone |
EMEA/H/C/004149 |
Vanda Pharmaceuticals Ltd |
|
Refused |
Zoonotic Influenza Vaccine Seqirus |
Human |
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) |
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23) |
EMEA/H/C/006375 |
Seqirus S.r.l. |
|
Authorised |
Zeftera (previously Zevtera) |
Human |
ceftobiprole |
ceftobiprole medocaril |
EMEA/H/C/000883 |
Janssen-Cilag International NV |
|
Refused |
Impulsor |
Human |
milnacipran |
milnacipran |
EMEA/H/C/001122 |
Pierre Fabre Medicament |
|
Refused |
Milnacipran Pierre Fabre Medicament |
Human |
milnacipran |
milnacipran |
EMEA/H/C/001034 |
Pierre Fabre Medicament |
|
Refused |
Sovrima |
Human |
idebenone |
idebenone |
EMEA/H/C/000908 |
Centocor B.V. |
|
Refused |
Zelnorm |
Human |
tegaserod |
tegaserod |
EMEA/H/C/000621 |
Novartis Europharm Limited |
|
Refused |
Rhucin |
Human |
recombinant human C1 inhibitor |
recombinant human C1 inhibitor |
EMEA/H/C/000769 |
Pharming Group N.V. |
|
Refused |
Turalio |
Human |
Pexidartinib |
Pexidartinib |
EMEA/H/C/004832 |
Daiichi Sankyo Europe GmbH |
|
Refused |
Aplidin |
Human |
|
|
EMEA/H/C/004354 |
|
|
|