Qsiva |
Human |
phentermine, topiramate |
phentermine, topiramate |
EMEA/H/C/002350 |
Vivus BV |
|
Refused |
Labazenit |
Human |
budesonide, salmeterol |
Budesonide, salmeterol |
EMEA/H/C/002201 |
Laboratoires SMB S.A. |
|
Refused |
Istodax |
Human |
romidepsin |
romidepsin |
EMEA/H/C/002122 |
Celgene Europe Ltd. |
|
Refused |
Acrescent |
Human |
memantine hydrochloride, donepezil hydrochloride |
memantine hydrochloride, donepezil hydrochloride |
EMEA/H/C/002424 |
H. Lundbeck A/S |
|
Refused |
Balaxur |
Human |
memantine hydrochloride, donepezil hydrochloride |
memantine hydrochloride, donepezil hydrochloride |
EMEA/H/C/002708 |
Merz Pharmaceuticals GmbH |
|
Refused |
Nouryant |
Human |
istradefylline |
Istradefylline |
EMEA/H/C/005308 |
Kyowa Kirin Holdings B.V. |
|
Refused |
Longrange |
Veterinary |
eprinomectin |
eprinomectin |
EMEA/V/C/004291 |
Merial |
|
Refused |
Eladynos |
Human |
abaloparatide |
abaloparatide |
EMEA/H/C/004157 |
Radius Health Ireland Ltd |
|
Refused |
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Withdrawn |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 |