| Cystadrops |
Human |
mercaptamine |
mercaptamine hydrochloride |
EMEA/H/C/003769 |
Recordati Rare Diseases |
2017/01/18
|
Authorised |
| Movymia |
Human |
teriparatide |
teriparatide |
EMEA/H/C/004368 |
STADA Arzneimittel AG |
2017/01/11
|
Authorised |
| Suliqua |
Human |
insulin glargine;lixisenatide |
insulin glargine;lixisenatide |
EMEA/H/C/004243 |
Sanofi Winthrop Industrie |
2017/01/11
|
Authorised |
| Talmanco (previously Tadalafil Generics) |
Human |
tadalafil |
tadalafil |
EMEA/H/C/004297 |
Viatris Limited |
2017/01/09
|
Authorised |
| Vemlidy |
Human |
tenofovir alafenamide |
tenofovir alafenamide fumarate |
EMEA/H/C/004169 |
Gilead Sciences Ireland UC |
2017/01/09
|
Authorised |
| Fiasp |
Human |
insulin aspart |
insulin aspart |
EMEA/H/C/004046 |
Novo Nordisk A/S |
2017/01/09
|
Authorised |
| Terrosa |
Human |
teriparatide |
teriparatide |
EMEA/H/C/003916 |
Gedeon Richter Plc. |
2017/01/04
|
Authorised |
| Afstyla |
Human |
lonoctocog alfa |
lonoctocog alfa |
EMEA/H/C/004075 |
CSL Behring GmbH |
2017/01/04
|
Authorised |
| Darunavir Viatris (previously Darunavir Mylan) |
Human |
darunavir |
darunavir |
EMEA/H/C/004068 |
Viatris Limited |
2017/01/03
|
Authorised |
| Lusduna |
Human |
insulin glargine |
insulin glargine |
EMEA/H/C/004101 |
Merck Sharp & Dohme B.V. |
2017/01/03
|
Withdrawn |
| Emtricitabine/Tenofovir disoproxil Mylan |
Human |
emtricitabine;tenofovir disoproxil |
emtricitabine;tenofovir disoproxil maleate |
EMEA/H/C/004050 |
Mylan Pharmaceuticals Limited |
2016/12/16
|
Authorised |
| Ocaliva |
Human |
obeticholic acid |
obeticholic acid |
EMEA/H/C/004093 |
Advanz Pharma Limited |
2016/12/12
|
Revoked |
| Rekovelle |
Human |
follitropin delta |
follitropin delta |
EMEA/H/C/003994 |
Ferring Pharmaceuticals A/S |
2016/12/12
|
Authorised |
| 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 |