| Emtricitabine/Tenofovir disoproxil Krka |
Human |
emtricitabine;tenofovir disoproxil |
emtricitabine;tenofovir disoproxil succinate |
EMEA/H/C/004215 |
KRKA, d.d., Novo mesto |
2016/12/09
|
Authorised |
| Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan) |
Human |
tenofovir disoproxil |
tenofovir disoproxil |
EMEA/H/C/004049 |
Viatris Limited |
2016/12/08
|
Authorised |
| SomaKit TOC |
Human |
edotreotide |
edotreotide |
EMEA/H/C/004140 |
Advanced Accelerator Applications |
2016/12/08
|
Authorised |
| Venclyxto |
Human |
venetoclax |
venetoclax |
EMEA/H/C/004106 |
AbbVie Deutschland GmbH & Co. KG |
2016/12/04
|
Authorised |
| Ninlaro |
Human |
ixazomib |
ixazomib citrate |
EMEA/H/C/003844 |
Takeda Pharma A/S |
2016/11/21
|
Authorised |
| Granpidam |
Human |
sildenafil |
sildenafil citrate |
EMEA/H/C/004289 |
Accord Healthcare S.L.U. |
2016/11/14
|
Authorised |
| Ivabradine Zentiva |
Human |
ivabradine |
ivabradine hydrochloride |
EMEA/H/C/004117 |
Zentiva, k.s. |
2016/11/11
|
Authorised |
| Glyxambi |
Human |
empagliflozin;linagliptin |
empagliflozin;linagliptin |
EMEA/H/C/003833 |
Boehringer Ingelheim International GmbH |
2016/11/11
|
Authorised |
| Parsabiv |
Human |
etelcalcetide |
etelcalcetide hydrochloride |
EMEA/H/C/003995 |
Amgen Europe B.V. |
2016/11/11
|
Authorised |
| Ivabradine JensonR |
Human |
ivabradine |
ivabradine hydrochloride |
EMEA/H/C/004217 |
JensonR+ Limited |
2016/11/11
|
Withdrawn |
| Ibrance |
Human |
palbociclib |
Palbociclib |
EMEA/H/C/003853 |
Pfizer Europe MA EEIG |
2016/11/09
|
Authorised |
| Emtricitabine/Tenofovir disoproxil Zentiva |
Human |
emtricitabine;tenofovir disoproxil |
emtricitabine;tenofovir disoproxil phosphate |
EMEA/H/C/004137 |
Zentiva k.s. |
2016/11/09
|
Authorised |
| Lartruvo |
Human |
olaratumab |
olaratumab |
EMEA/H/C/004216 |
Eli Lilly Nederland B.V. |
2016/11/09
|
Revoked |
| Onivyde pegylated liposomal (previously Onivyde) |
Human |
irinotecan hydrochloride trihydrate |
irinotecan anhydrous free-base |
EMEA/H/C/004125 |
Les Laboratoires Servier |
2016/10/14
|
Authorised |
| Truberzi |
Human |
eluxadoline |
eluxadoline |
EMEA/H/C/004098 |
Allergan Pharmaceuticals International Limited |
2016/09/19
|
Withdrawn |
| Mysildecard |
Human |
sildenafil |
|
EMEA/H/C/004186 |
Viatris Limited |
2016/09/15
|
Authorised |
| Inhixa |
Human |
enoxaparin sodium |
enoxaparin sodium |
EMEA/H/C/004264 |
Techdow Pharma Netherlands B.V. |
2016/09/15
|
Authorised |
| Sialanar |
Human |
glycopyrronium bromide |
glycopyrronium bromide |
EMEA/H/C/003883 |
Proveca Pharma Limited |
2016/09/15
|
Authorised |
| Tenofovir disoproxil Zentiva |
Human |
tenofovir disoproxil |
tenofovir disoproxil phosphate |
EMEA/H/C/004120 |
Zentiva k.s. |
2016/09/15
|
Authorised |
| Thorinane |
Human |
enoxaparin sodium |
enoxaparin sodium |
EMEA/H/C/003795 |
Pharmathen S.A. |
2016/09/14
|
Lapsed |