| Sildenafil Actavis |
Human |
sildenafil |
sildenafil |
EMEA/H/C/001090 |
Actavis Group PTC ehf |
2009/12/10
|
Authorised |
| Lamivudine Teva Pharma B.V. |
Human |
lamivudine |
lamivudine |
EMEA/H/C/001111 |
Teva B.V. |
2009/12/10
|
Authorised |
| Olazax Disperzi |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001088 |
Glenmark Pharmaceuticals s.r.o. |
2009/12/10
|
Authorised |
| Prevenar 13 |
Human |
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) |
Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F |
EMEA/H/C/001104 |
Pfizer Europe MA EEIG |
2009/12/09
|
Authorised |
| Olanzapine Glenmark Europe |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001086 |
Glenmark Arzneimittel GmbH |
2009/12/03
|
Authorised |
| Olanzapine Glenmark |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001085 |
Glenmark Arzneimittel GmbH |
2009/12/03
|
Authorised |
| Hirobriz Breezhaler |
Human |
indacaterol |
indacaterol maleate |
EMEA/H/C/001211 |
Novartis Europharm Limited |
2009/11/30
|
Authorised |
| Zutectra |
Human |
human hepatitis B immunoglobulin |
human hepatitis B immunoglobulin |
EMEA/H/C/001089 |
Biotest Pharma GmbH |
2009/11/30
|
Authorised |
| Nevirapine Teva |
Human |
nevirapine |
nevirapine |
EMEA/H/C/001119 |
Teva B.V. |
2009/11/30
|
Withdrawn |
| Sildenafil Teva |
Human |
sildenafil |
sildenafil |
EMEA/H/C/001073 |
Teva B.V. |
2009/11/30
|
Authorised |
| Oslif Breezhaler |
Human |
indacaterol |
indacaterol maleate |
EMEA/H/C/001210 |
Novartis Europharm Limited |
2009/11/29
|
Authorised |
| Onbrez Breezhaler |
Human |
indacaterol |
indacaterol maleate |
EMEA/H/C/001114 |
Novartis Europharm Limited |
2009/11/29
|
Authorised |
| Irbesartan/Hydrochlorothiazide Teva |
Human |
irbesartan;hydrochlorothiazide |
irbesartan;hydrochlorothiazide |
EMEA/H/C/001112 |
Teva B.V. |
2009/11/26
|
Authorised |
| Multaq |
Human |
dronedarone |
dronedarone |
EMEA/H/C/001043 |
Sanofi Winthrop Industrie |
2009/11/25
|
Authorised |
| Copalia HCT |
Human |
amlodipine;valsartan;hydrochlorothiazide |
amlodipine;valsartan;hydrochlorothiazide |
EMEA/H/C/001159 |
Novartis Europharm Limited |
2009/11/03
|
Authorised |
| Dafiro HCT |
Human |
amlodipine besilate;valsartan;hydrochlorothiazide |
valsartan;hydrochlorothiazide;amlodipine besilate |
EMEA/H/C/001160 |
Novartis Europharm Limited |
2009/11/03
|
Authorised |
| Repaglinide Krka |
Human |
repaglinide |
repaglinide |
EMEA/H/C/001066 |
Krka, d.d., Novo mesto |
2009/11/03
|
Authorised |
| Irbesartan Teva |
Human |
irbesartan |
irbesartan |
EMEA/H/C/001093 |
Teva B.V. |
2009/10/30
|
Authorised |
| Eporatio |
Human |
epoetin theta |
epoetin theta |
EMEA/H/C/001033 |
Ratiopharm GmbH |
2009/10/29
|
Authorised |
| Ilaris |
Human |
canakinumab |
Canakinumab |
EMEA/H/C/001109 |
Novartis Europharm Limited |
2009/10/23
|
Authorised |