| Esmya |
Human |
ulipristal |
ulipristal acetate |
EMEA/H/C/002041 |
Gedeon Richter Ltd |
2012/02/22
|
Withdrawn |
| Zelboraf |
Human |
vemurafenib |
vemurafenib |
EMEA/H/C/002409 |
Roche Registration GmbH |
2012/02/17
|
Authorised |
| Vepacel |
Human |
prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture) |
Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1) |
EMEA/H/C/002089 |
Ology Bioservices Ireland LTD |
2012/02/17
|
Withdrawn |
| Caprelsa |
Human |
vandetanib |
vandetanib |
EMEA/H/C/002315 |
Sanofi B.V. |
2012/02/16
|
Authorised |
| Colobreathe |
Human |
colistimethate sodium |
Colistimethate sodium |
EMEA/H/C/001225 |
Essential Pharma Limited |
2012/02/13
|
Authorised |
| Docetaxel Mylan |
Human |
docetaxel |
docetaxel |
EMEA/H/C/002317 |
Mylan S.A.S. |
2012/01/31
|
Lapsed |
| Desloratadine Actavis |
Human |
desloratadine |
desloratadine |
EMEA/H/C/002435 |
Actavis Group PTC ehf |
2012/01/13
|
Authorised |
| Desloratadine ratiopharm |
Human |
desloratadine |
desloratadine |
EMEA/H/C/002404 |
Ratiopharm GmbH |
2012/01/13
|
Authorised |
| Efavirenz Teva |
Human |
efavirenz |
efavirenz |
EMEA/H/C/002352 |
Teva B.V. |
2012/01/09
|
Authorised |
| Activyl Tick Plus |
Veterinary |
indoxacarb;permethrin |
indoxacarb;permethrin |
EMEA/V/C/002234 |
Intervet International BV |
2012/01/09
|
Withdrawn |
| Repaglinide Accord |
Human |
repaglinide |
repaglinide |
EMEA/H/C/002318 |
Accord Healthcare S.L.U. |
2011/12/22
|
Authorised |
| Topotecan Eagle |
Human |
topotecan |
topotecan hydrochloride |
EMEA/H/C/002261 |
Eagle Laboratories Ltd. |
2011/12/22
|
Withdrawn |
| Levetiracetam Sun |
Human |
levetiracetam |
levetiracetam |
EMEA/H/C/002051 |
Sun Pharmaceutical Industries Europe B.V. |
2011/12/14
|
Authorised |
| TruScient |
Veterinary |
dibotermin alfa |
dibotermin alfa |
EMEA/V/C/002000 |
Zoetis Belgium SA |
2011/12/14
|
Withdrawn |
| Ameluz |
Human |
5-aminolevulinic acid hydrochloride |
5-aminolevulinic acid hydrochloride |
EMEA/H/C/002204 |
Biofrontera Bioscience GmbH |
2011/12/13
|
Authorised |
| Edarbi |
Human |
azilsartan medoxomil |
azilsartan medoxomil |
EMEA/H/C/002293 |
Takeda Pharma A/S |
2011/12/07
|
Authorised |
| Ipreziv |
Human |
azilsartan medoxomil |
azilsartan medoxomil |
EMEA/H/C/002517 |
Takeda Pharma A/S |
2011/12/07
|
Withdrawn |
| Dificlir |
Human |
fidaxomicin |
fidaxomicin |
EMEA/H/C/002087 |
Tillotts Pharma GmbH |
2011/12/05
|
Authorised |
| Levetiracetam Actavis Group |
Human |
levetiracetam |
levetiracetam |
EMEA/H/C/002305 |
Actavis Group PTC ehf |
2011/12/04
|
Authorised |
| Edurant |
Human |
rilpivirine |
rilpivirine hydrochloride |
EMEA/H/C/002264 |
Janssen-Cilag International N.V. |
2011/11/28
|
Authorised |